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Contact LensSPECTRUM

S P E C I A L E D I T I O N 2 0 1 4

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Breaking the Cycle of Discomfort

ALSO IN THIS ISSUE

■ Contact Lens Discomfort Defined

■ Preventing Dehydration Blur

■ Growing a Practice With a Novel Contact Lens Technology

Advanced contact lens materials and manufacturing process deliver exceptional comfort*

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®/™ are trademarks of Bausch & Lomb Incorporated or its affiliates. All other product/brand names are trademarks of their respective owners.©2014 Bausch & Lomb Incorporated. US/ZUS/14/0149

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F E A T U R E SContact Lens Discomfort DefinedBy Katherine M. Bickle, OD, MS & Kelly K. Nichols, OD, MPH, PhD

Each year, patients in our practices are struggling with lens wear, and in some cases, dropping silently out of lens wear. How do we get to the bottom of this problem?

Breaking the Cycle of DiscomfortBy Katarzyna Wygladacz, MS, PhD; Daniel Hook, BS, MS, PhD; Robert Steffen, OD, MS & Wil l iam Reindel, OD, MS

Advanced contact lens materials and manufacturing process deliver exceptional comfort.*

Clinical Performance of Samfilcon A Silicone Hydrogel Contact LensesBy Robert Steffen, OD, MS; Mohinder M. Merchea, OD, PhD, MBA; Marjorie J . Rah, OD, PhD & Wil l iam Reindel, OD, MS

New technology aims to make lens wear more comfortable despite increased digital viewing.

Preventing Dehydration BlurBy Kristen R. Hovinga, MS; Paul D. Ludington, MS, Mohinder Merchea, OD, PhD, MBA, & Robert Steffen, OD, MS

The increased use of digital devices in today’s society has made it more important than ever to address lens dehydration.

A One-Step Hydrogen Peroxide-based Contact Lens SolutionBy Kimberly A. Mil lard, MS; Daniel Hook, PhD;Andrew Hoteling, PhD & Katarzyna Wygladacz, PhD

Development of a cleaning and disinfecting solution with a platinum-modulating compound.

Growing My Practice With a Novel Contact Lens TechnologyBy Matthew Ward, OD

Even when patients say, “I’m happy with the lens I have.”

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Different approaches for PVP entanglement PAGE 26

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D E P A R T M E N T S

Editor’s PerspectiveBy Jason J. Nichols, OD, MPH, PhD, FAAONew Concepts Aimed at Improving Vision and Comfort

Research ReviewBy S. Barry Eiden, OD, FAAOResearch About the Ocular Surface and Contact Lens Wear

Refractive FocusBy Katherine M. Bickle, OD, MS & David Berntsen, OD, PhD, FAAOThe Impact of Dry Eye on Visual Performance

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*MoistureSeal technology, as part of the Bausch + Lomb Ultra contact lens material (samfilcon A), represents a significant achievement in integrating novel material chemistry and a two-phase manufacturing process to produce a unique silicone hydrogel lens designed to address the cycle of discomfort many wearers encounter each day and enhance the overall lens wearing experience particularly at the end of the day.

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EDITOR-IN-CHIEFJason J. Nichols, OD, MPH, PhD, FAAO

2008-Present

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2007-Present

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(215) [email protected]

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SPECIAL PROJECTSEDITORIAL DIRECTOR Angela Jackson

(215) [email protected]

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FOUNDING EDITORNeal J. Bailey, OD, PhD

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EDITORS EMERITUSJoseph T. Barr, OD, MS, FAAO

1987-2007

Carla J. Mack, OD, MBA, FAAO2007-2008

COLUMNISTS

Online Photo DiagnosisLuciano Bastos

Gregory W. DeNaeyer, OD, FAAOWilliam Townsend, OD, FAAO

Research ReviewS. Barry Eiden, OD, FAAO

Eric Papas, PhD, MCOptom, DipCL FAAO

Refractive FocusDavid A. Berntsen, OD, PhD, FAAO

Jason Marsack, PhD

Prescribing for Presbyopia/AstigmatismTimothy B. Edrington, OD, MS, FAAO

Craig W. Norman, FCLSAThomas G. Quinn, OD, MS, FAAO

GP InsightsEdward S. Bennett, OD, MSEd, FAAO

John Mark Jackson, OD, MS, FAAO

Contact Lens Design & MaterialsDavid L. Kading, OD, FAAO

Neil Pence, OD, FAAORonald K. Watanabe, OD, FAAO

Dry Eye Dx and TxAmber Gaume Giannoni, OD, FAAO

Katherine M. Mastrota, MS, OD, FAAOWilliam Townsend, OD, FAAO

Contact Lens Care & ComplianceSusan J. Gromacki, OD, MS, FAAO

Michael A. Ward, MMSc, FAAO

Contact Lens Practice PearlsJessica H. Mathew, OD, PhD, FAAO

Jason R. Miller, OD, MBA, FAAOGregory J. Nixon, OD, FAAO

Is This the New Norm?Mile Brujic, OD

David L. Kading, OD, FAAO

The Business of Contact LensesGary Gerber, OD

Clarke D. Newman, OD, FAAO

Pediatric and Teen CL CareChristine W. Sindt, OD, FAAO

Jeffrey J. Walline, OD, PhD, FAAO

The Scleral Lens VaultGregory W. DeNaeyer, OD, FAAO

Treatment PlanWilliam L. Miller, OD, MS, PhD, FAAO

Leo Semes, OD, FAAO

Contact Lens Case ReportsMark P. André, FAAO

Patrick J. Caroline, FAAO

E-mail: [email protected]

Home page: www.clspectrum.com

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PENTAVISION LLC

PRESIDENT Thomas J. Wilson

EXECUTIVE VICE PRESIDENTS Mark Durrick, Douglas Parry, Robert Verna, Roger Zimmer

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D E P A R T M E N T S

Prescribing for PresbyopiaBy Thomas G. Quinn, OD, MS, FAAOPatient Characteristics Affect Multifocal Lens Performance

GP InsightsBy Edward S. Bennett, OD, MSEd, FAAOUsing Peroxide With GP Lenses

Contact Lens Design & MaterialsBy Neil Pence, OD, FAAOCharacteristics of a New Silicone Hydrogel Contact Lens

Dry Eye Dx and TxBy Katherine M. Mastrota, MS, OD, FAAOOcular Surface and Tear Film in Contact Lens Discomfort

Contact Lens Care & ComplianceBy Michael A. Ward, MMSC, FAAONew Option for Peroxide Disinfection

Contact Lens Practice PearlsBy Jason R. Miller, OD, MBA, FAAOThe Contact Lens Conversation

The Business of Contact LensesBy Gary Gerber, ODAssessing the Value of Adding New Technology

Pediatric & Teen CL CareBy Jeffrey J. Walline, OD, PhD, FAAOMyopia Control Consent Form

Treatment PlanBy William L. Miller, OD, MS, PhD, FAAOLearnings from the Contact Lens Discomfort Workshop

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1 Based on patient satisfaction study. 2 Based on 2855 multi-purpose users asked to try Biotrue for about 7 days.© 2014 Bausch & Lomb Incorporated. ®/™ are trademarks of Bausch & Lomb Incorporated or its a liates. PNS07238 HL6195

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When treating irregular corneas with a soft lens, there was a time when “thickness of material” was thought to be the best approach. Today, there is KeraSoft® IC. Its patented design “drapes” over the cornea to correct the vision rather than simply “mask” the irregularity. This enables KeraSoft® IC to have a thinner optical center than in traditional designs, while still providing excellent visual acuity – a signifi cant factor to consider when choosing a lens that meets your patient’s needs. And for comfort, KeraSoft® IC is made of a quarterly replacement silicone hydrogel*.*Defi nitive Material.

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TNew Concepts Aimed at Improving Vision and Comfortechnology is continually expanding and moving boundaries for us in all aspects of our lives. It is truly amazing and exciting to see the conveniences that new technologies afford us each day. On the other hand, technology creates occasional headaches — literally and figuratively in the medical sense.

Computers and other digital devices and their use, particularly over long periods of time, are clinically associated with a variety of ophthalmic-related conditions including headaches, eyestrain and fatigue, discomfort and dry eye. It is thought by some that these problems are further exacerbated by the use of contact lenses, but this is not entirely clear. There is no doubt that the optical quality and vision-related performance of a contact lens depends on a stable pre-lens tear film.

This special edition of Contact Lens Spectrum explores some of the challenges we face when patients come to us with complaints of fatigue, discomfort and the like.

Often, these problems are a challenge to manage given that employment or social needs mandate our patients’ use of technology. We as eye care practitioners need contact lens materials and designs that will help us overcome these challenges, allowing our patients to wear contact lenses in a variety of environments. In this special edition, you can learn more about one such technology, aimed at improving the wearing experience of our patients who use digital devices. I applaud manufacturers who are working to improve contact lens materials and designs that will allow for more satisfied patients and greater success in contact lens practice.

editor’s perspectiveB Y J A S O N J . N I C H O L S , O D , M P H , P H D , F A A O

Contact Lens Spectrum (ISSN 0885-9175) is a registered trademark of PentaVision LLC, published monthly with a special October 2014 edition. Advertising and editorial office: 321 Norristown Rd., Suite 150, Ambler, PA 19002. Subscrip-tions: United States 1 year $63, 2 years $111; Canada 1 year $80, 2 years $145. Other countries 1 year $118, 2 years $210 (must be prepaid in U.S. dollars). Single copies $8 each for the United States and Canada, $10 for all other locations. Pe-riodicals postage paid at Ambler, PA and additional mailing office. Copyright 2014 by PentaVision. Reproduction of all or part of this publication without the consent of the publisher is prohibited. For subscription information/address changes: Contact Lens Spectrum, P.O. Box 3076, Northbrook, IL 60065; (800) 306-6332 or Fax (847) 564-9453.

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to continue to better understand how to manage patients with ocular surface disease (with or without contact lens wear). Let’s look at some of the most current research in this area and see how it furthers our understanding.

General Perspectives of Dry Eye and Ocular Surface DiseaseA recent publication authored by many of the original DEWS participants evaluated where we are in the understanding of dry eye disease (DED) since the original DEWS report was published in 2007 (Bron et al). They once again reviewed some of the most impactful research studies over the past 5 years. The authors made a number of key clinical conclusions follow-ing their literature review, which suggested that a rethinking of traditional concepts of dry eye is needed. They stated that “DED is not simply an inconvenience, but rather a bonafide disease with important clinical implications.” Further, DED has two major sub-types, aqueous deficient dry eye (ADDE) and evaporative dry eye (EDE), the most common form of which is meibomian gland dys-function (MGD). A critical con-

Research ReviewB Y S . B A R R Y E I D E N , O D , F A A O

OResearch About the Ocular Surface and Contact Lens Wear

ur understanding of the critical importance of a healthy ocular surface for successful contact lens wear is becoming more apparent as research continues to tell us of the intimate relationship

between the two. Over the past few years, landmark efforts have been made to clarify our under-standing of this relationship as expressed by three international workshops held by the Tear Film and Ocular Surface Society (TFOS):

1. The International Dry Eye Workshop (DEWS) 2007 (DEWS Report, 2007)

2. The International Work-shop on Meibomian Gland Dysfunction 2011 (Nichols et al, 2011)

3. The International Work-shop on Contact Lens Discomfort 2013 (Nichols et al, 2013)

These workshops each brought together the leading experts in their fields to organize current knowledge and encapsulate cur-rent approaches to diagnosis and management of these clinically challenging entities. As stated by the authors, “The International workshops provide a consensus overview of the field as a snap-shot in time.” The documents published are based on extensive international literature reviews of current research. They give us a heretofore unavailable evidence-based foundation from which ongoing research will allow us

clusion was that although most patients present with symptoms, a significant number of patients with objective evidence of disease are asymptomatic. Diagnosis by symptoms alone is insufficient. Additionally, all objective tests for DED are variable in patients with DED. This variability isn’t seen in healthy individuals. As an example, with effective treatment, tear osmolarity has been reported to return to normal, and the variability found prior to treat-ment is reduced. Finally, the authors stated that many new therapeutic approaches are under development, including anti-inflammatory agents, secretory stimulants, tear film stabilizers, and others. With incorporation of improved endpoints for clinical trials, it’s likely that a variety of therapeutic agents will emerge in the foreseeable future.

Taking a simpler approach, a group of European dry eye experts (ODISSEY European Consensus Group) met to come up with a consensus approach to the diagnosis and severity grad-ing of dry eye disease (Baudouin et al, 2014). The authors stated that due to its multifactorial nature, clinical and biological signs of DED can be inconsis-tent and sometimes discordant with symptomatology. Using a consensus-based approach, the group assessed 14 commonly used DED severity criteria. The panel agreed that following confirmed DED diagnosis, just two crite-

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ria, symptom-based assessment and corneal fluorescein staining were sufficient to diagnose the presence of severe DED in the majority of patients. In the event of discordance between signs and symptoms, further evaluation using additional determinant criteria was recommended.

Evolving Technologies in the Diagnosis of Dry Eye DiseaseA review of currently avail-able and emerging technologies utilized in the diagnosis and evaluation of dry eye disease was recently published. In addition to a group of commonly performed diagnostic tests and procedures, the authors reviewed a number of new technologies in develop-ment (Zeev et al, 2014). Optical coherence tomography (OCT) of the anterior segment is able to measure the inferior tear menis-cus height with the advantage of being objective, reproducible and non-invasive. A developing system for tear meniscus height measures utilizes reflective meniscometry. Measured with a slit lamp-mount-ed instrument, this technology seems to be as reliable as OCT — but much less expensive. Tear film stability can be measured us-ing modified videokeratography systems. The software analyzes dynamic changes in tear film stability over a 10 second time period and quantifies the results with measures of surface regular-ity and surface asymmetry. Simi-larly, aberrometry is being used to evaluate dry eye influences on higher order aberrations (HOAs), both in terms of overall degrees of HOAs as well as dynamic changes in HOAs over specific time pe-riods. Tear film interferometry measures the lipid layer thickness,

which is reduced in cases of MGD and EDE. Some instruments such as LipiView (Tear Science) can quantify lipid layer thickness while other less expensive sys-tems such as the Keratograph 5M (Oculus) can record video images of the lipid layer, and via subjec-tive observation of the bifringence color pattern, lipid layer thickness can be estimated. Meibomography allows the clinician to view the meibomian glands (MGs). A num-ber of systems (such as the Kera-tograph 5M) have been developed and grading scales determining the degree of MG loss (atrophy) have been proposed. Biomarkers in the tear film can be measured clinically to provide diagnostic information regarding ocular surface disease. For example, the recently introduced InflammaDry test (Rapid Pathogen Screening) detects elevated levels of matrix metalloproteinase-9 in the tear film, which is an inflammatory biomarker common to dry eye. Measurements of lactoferrin and IGE in the tear film as measured by the TearScan Microassay Sys-tem (Advanced Tear Diagnostics) can help the clinician differentiate allergic eye findings from dry eye or determine that both are pres-ent. Ocular surface and tear film temperature diurnal variations have been shown to be greater in dry eye disease as compared to normal eyes. Ocular surface ther-mography systems have been in-troduced that may have diagnostic value in DED.

MGD, Dry Eye and Contact Lens WearThe relationship between MGD and dry eye has been conclu-sively shown to be strong. In fact, the authors of the International

Workshop on Meibomian Gland Dysfunction state that MGD is now considered the leading cause of dry eye (Nichols et al, 2011). Ongoing research into MGD is allowing us to better diagnose and treat this condition.

Recently, researchers in China again confirmed the relation-ship between MGD and dry eye (Feng et al, 2014). 264 randomly selected patients (528 eyes) suf-fering from dry eye disease were enrolled in the study. Tear-film break-up time (TBUT) was mea-sured and tear-film production was evaluated by the Schirmer test I (SIT). Subjective symptoms were also scored. Meibomian glands were observed using a non-contact meibography system. Meibomian dropout was scored for each eyelid. SIT and TBUT were significantly negatively cor-related with the meibomian gland photographic score, whereas corneal fluorescein staining was positively correlated. The authors concluded that a large proportion of meibomian dropout cases were found among patients with DED, indicating that treatment targeted at the meibomian gland will con-tinue to be an important direction for treating DED. They felt that meibography is recommended as a routine test for dry eye disease.

A Japanese study evaluated the relationship between contact lens wear and meibomian gland drop out (Arita et al, 2009). A group of contact lens wearers and an age matched group of non-contact lens wearing healthy controls were evaluated with the following tests: slit-lamp examinations of the eyelids, corneal and conjunc-tival staining using fluorescein, measurement of tear film TBUT, noncontact meibography, and


measurement of tear produc-tion using the Schirmer I test. Results showed the meiboscore, which measures meibomian gland drop out, was significantly higher (P<0.0001) in CL wearers than in the control group. The average meiboscore of CL wearers was similar to that of a 60- to 69-year-old age group from the normal population. A significant positive correlation was observed between the duration of CL wear and the meiboscore. Contact lens wear was associated with a decrease in the number of functional meibo-mian glands and this decrease was proportional to the duration of CL wear.

Contact Lenses and Dry EyeDry eye symptoms are one of the most common complaints from contact lens wearers and have been reported to be a major rea-son for discontinuation and drop out from contact lens wear. A multicenter prospective study was conducted that evaluated a group of soft contact lens (SCL) wearers who reported significant SCL-related dryness symptoms (Young et al, 2012). The group was com-prised of both patients with de-finitive ocular signs of dryness and patients with no observable signs of dryness. The symptomatic SCL wearers reported significant SCL-related dryness symptoms via a self-administered questionnaire of frequency and intensity of dryness following a dry eye (DE) physical eye examination. DE etiology was assigned post hoc by an expert panel, and those with and without significant DE-related signs were analyzed by univariate logistic regression. Possible DE etiolo-gies were aqueous tear deficiency, SCL-induced tear instability,

meibomian gland dysfunction, or “other.” Wearers without signs that qualified for any DE etiology were designated as No DE Signs (NDES). Results indicated that of the 226 SCL symptomatic wear-ers examined, 23% were without signs, 30% had evidence of aque-ous tear deficiency, 25% had evi-dence of SCL-induced tear insta-bility, 14% had meibomian gland dysfunction, and 8% had “other” diagnoses. The NDES wearers were significantly more likely to be male (36% vs.19%, p = 0.013),

were less likely to have deteriorat-ing comfort during the day (81% vs. 97%, p = 0.001) and reported longer average hours of comfort-able wear (11 ± 3 vs. 9 ± 4 h, p = 0.014). The researchers con-cluded that symptoms of dryness in SCL wearers stem from a va-riety of underlying causes. How-ever, nearly one-quarter of these symptomatic SCL wearers appear to be free of clinical signs of dry-ness. They stated that the effec-tive management of CL-related dryness requires a comprehensive range of clinical assessments and the use of a diverse range of man-

agement strategies. Over the past number of years,

there has been a great resur-gence in the fitting of scleral gas permeable contact lenses. One of the key proposed indications for scleral lens fitting is for the management of ocular surface diseases. A retrospective study was conducted at a tertiary refer-ral center in order to describe the management of ocular surface disease with commercially avail-able scleral lenses (Schornack et al, 2014). Researchers reviewed the medical records and analyzed a survey mailed to all patients who completed the scleral lens fitting process to evaluate the long-term success of scleral lens therapy in the management of ocular surface disease. Of the 212 subjects, 115 (188 eyes) success-fully completed the scleral lens fitting process, and therapeutic goals (improved comfort, ocular surface protection, or resolution of keratopathy) were achieved in all but 2 of these subjects. Visual acuity improved with scleral lens wear when compared to habitual correction. The most common indications for scleral lens therapy were undifferentiated ocular sur-face disease, exposure keratopathy, and neurotrophic keratopathy. Subjects had attempted an aver-age of 3.2 (range, 0-8) other forms of intervention before scleral lens wear. Scleral lens fitting was completed in an average of 3 visits (range, 2-6), with an average of 1.4 lenses/eye (range, 1-4). Three patients experienced complica-tions during scleral lens wear that resolved without loss of visual acuity, enabling resumption of scleral lens wear. The conclusions of this study are that commercial-

Research Review


(Continued on page 10)

Contact lens wearers commonly suffer from dry eye symptoms that can be associated with

ocular surface disease and

exacerbated by contact lens wear.

Refractive FocusB Y K A T H E R I N E M . B I C K L E , O D , M S , & D A V I D A . B E R N T S E N , O D , P H D , F A A O

AThe Impact of Dry Eye on Visual Performance

A significant number of patients experience dry eye disease (DED) and seek relief of their dry eye symptoms. Beyond the subjective symp-toms of DED, what do we know about the

effect of DED-related visual dis-turbances on our patients’ daily activities?

Between 5-30% of individu-als are estimated to have DED (McCarty et al, 1998; Lin et al, 2003). DED can be challenging for not only the patient but for the eye care professional diagnos-ing and implementing treatment due to the lack of correlation between signs and symptoms (Nichols et al, 2004). There is not one specific test that definitively confirms a DED diagnosis. Tear film instability (Tutt et al, 2000; Montes-Mico et al, 2004; Begley et al, 2006) and a decreased tear break-up time can cause transient visual disturbances, while cen-trally located superficial punctate keratitis can result in constant symptoms that include decreased visual acuity (Huang et al, 2002) and decreased reading speed (Ridder 3rd et al, 2013).

Eye care providers strive to find an appropriate balance when factoring in patient signs and symptoms to properly diagnose and treat their patients. Visual symptoms for dry eye patients can vary dramatically in frequency and severity. The differences in visual demands, which are unique

those with definite DED (4.82%) compared to those without DED (3.56%). Factoring in the average annual salary of the employees affected by DED, they estimated wage losses of $1,178 with over-all company production losses averaging $6,160. Reductions in time management and both mental and interpersonal func-tion were also found to be related to DED, demonstrating that the impact of patients’ symptoms on everyday life can be dramatic. By understanding and treating your

patient’s symptoms, we are not only making them more comfort-able but also potentially reducing workplace productivity loss. What about the influence of DED on non-work activities?

Dry Eye Disease and Daily LifeDriving response times are slower in patients with DED than those without DED (Deschamps et al, 2013). Response times have been shown to be correlated with cor-neal higher-order aberrations, indicating that disruptions in the tear film may play a factor in driv-

to each patient, make it difficult to test patients under their spe-cific conditions in an exam room setting. However, this should not discourage you from obtaining a thorough history to determine the conditions in which your pa-

tients are most bothered by visual disturbances and their impact on the patient’s daily life. A patient may report blurred vision, yet is able to read 20/20. How might this influence their work perfor-mance?

The Economic BurdenA recent study conducted in Japan evaluated work productiv-ity and performance in those without DED, probable DED, and definite DED (Uchino et al, 2014). Total workplace produc-tivity loss was slightly greater in


The differences in visual demands, which are unique to each patient, make it difficult to test patients under their specific conditions

in an exam room setting.

Dr. Bickle is a PhD student at The Ohio State University College of Optometry and is in pri-vate practice in Granville, Ohio. Dr. Berntsen is an assistant professor at the University of Houston College of Optometry. He has received research funding from the Johnson & Johnson Vision Care Institute and Alcon.

ing safety. While we often consid-er how clinical signs or symptoms (e.g., dryness, burning, irritation, redness, and grittiness) will im-prove with various treatment op-tions, we should also consider the impact this will potentially have on the patient’s quality of life and safety.

While patients with DED may complain of visual fluctuations, why might you not find reduc-

tions in visual acuity during your examination? While DED can disrupt the tear film, patients are able to blink and re-establish the tear film momentarily dur-ing these tasks so that you do not detect a reduction in visual acuity (Ridder 3rd et al, 2013). However, the effect of DED on visual func-tion is more likely to be observed when functional factors such as reading speed are evaluated. Average reading speed for DED patients (134.9 words per minute) have been shown to be slower than for normal patients (158.3 words per minute), demonstrating the functional effect of DED on daily visual tasks. How can you be most effective and efficient at understanding the symptoms of this type of patient?

Application in the Clinical Setting

Understanding specific situa-tions in which patients have been

shown to experience visual dis-turbances due to DED allows you to ask targeted questions (e.g., questions related to read-ing, driving, use of electronic devices, etc.). This can help you better understand the patient who reports sometimes vague issues regarding visual perfor-mance but has 20/20 Snellen acuity. Questionnaires can also be administered by your staff to quickly address specific DED-related questions. Being able to review the patient’s responses prior to your examination allows for a more efficient and targeted patient history. DED patients are more likely to report difficulties with reading (odds ratio [OR] = 3.64), watching television (OR= 2.84), completing professional work (OR= 3.49), and driving during the day (OR = 2.80) and night (OR=2.20) on surveys (Miljanovic et al, 2007). At follow-up visits, patients can complete the same questionnaires to assess for improvements in these areas after treatment.

In summary, studies demon-strating a relationship between symptoms and daily tasks can aid in asking targeted questions about difficulties that your dry eye patients may experience but do not know how to report during an eye examination. Understanding these relationships can allow you to more effectively identify DED-related issues so that you can quickly diagnose and treat these patients. CLS

For references, please visit www.clspectrum.com/references.asp and click on document #SE2014.


Refractive Focus

The effect of DED on visual function is more likely to be

observed when functional factors such as reading

speed are evaluated.

Research Review

Dr. Eiden is president and medical director of North Suburban Vision Consultants, president and medical director of the National Kerato-conus Institute, and co-founder of EyeVis Eye and Vision Research Institute. He is an adjunct faculty member at The University of Illinois Medical Center, as well as at the Indiana and Illinois Colleges of Optometry and Pennsylva-nia College of Optometry at Salus University. He is also a consultant or an advisor to Alcon, Alden Optical, Bausch + Lomb, CooperVision, Diopsys, Oculus, Paragon Vision Sciences, SpecialEyes and Visionary Optics.

ly available scleral lenses can be successfully used in the manage-ment of moderate to severe ocular surface disease. The scleral lens fitting process can be completed efficiently for most eyes by using diagnostic trial lenses. In addition to protecting the ocular surface, scleral lenses improve visual acu-ity in patients whose surface dis-ease has compromised vision.

ConclusionOcular surface disease and specifi-cally DED is a major challenge to both eye care practitioners and to their patients. Contact lens wear-ers commonly suffer from dry eye symptoms that can be associated with ocular surface disease and exacerbated by contact lens wear. Ongoing research gives us a much clearer understanding of these diseases and their relationship to contact lens wear. Outcomes from this research allow us as eye care practitioners to better manage our patients and allow them to experience clear, comfortable and healthy vision with contact lens wear. CLS

For references, please visit www.clspectrum.com/references and click on document #SE2014.

(Continued from page 8)

Research Review Prescribing for PresbyopiaB Y T H O M A S G . Q U I N N , O D , M S , F A A O

IPatient Characteristics Affect Multifocal Lens Performance

t’s common to consider lens design features when choosing a multifocal contact lens, but individual patient characteristics should be considered as well. Most contact lens fitters

understand the importance of pupil size and how it impacts the information received by the visual system through a simultaneous vi-sion multifocal contact lens. Pupil size is one of the primary reasons it’s best to over-refract a simulta-neous vision multifocal lens using loose lenses. Over-refracting be-hind a phoropter likely will lead to relative pupil dilation com-pared to what would be present in a more natural environment.

Although pupil size decreases with age, the change in size with illumination follows a similar slope for all age groups (Plainis et al, Oct. 2013). It is therefore important to consider light level when assessing multifocal contact lens performance on presbyopes of all ages.

Advancing age offers some benefits in that at least one study found subjects with small pupils to have better near vision than their counterparts when wearing a center near soft multifocal lens design (Plainis et al, Jan. 2013).

Spherical AberrationThe good news for the more advanced presbyope with regard to pupil size is tempered, at least somewhat, by changes in ocular

of the patients’ visual needs with a multifocal contact lens. Ocular dominance can play a role in de-termining which eye is biased for distance and which for near.

Ocular DominanceMany contact lens providers as-sess ocular dominance by asking patients to line up an object while looking through outstretched hands, a tube, a camera, or some other similar device. This form of testing determines sighting domi-nance, which is a measure of how the body is wired, similar to iden-tifying the dominant hand (right or left). Schor and colleagues (1987) found ocular dominance determined via this method has little correlation with monovision or multifocal lens success.

However, evidence supports an approach that assesses dominance by introducing plus in front of each eye separately, under bin-ocular conditions, then determin-ing which disturbs distance vision more significantly (Robboy et al,1990; Collins and Goode,1994; Handa et al, 2005). The dominant eye is the one more bothered by the plus in front of it. Place the near biased multifocal contact lens on the other, more “tolerant,” non-dominant eye.

AdaptabilityWe all recognize that some pa-tients are more visually sensitive than others. Those with a more adaptable visual system tend to

spherical aberration over time. The same study that evaluated the impact of pupil size on visual performance of a center near soft multifocal lens also found a decrease in near acuity with higher levels of ocular spherical aberration, which, unfortunately, increases with age.

Degree of Presbyopia Of course, where the patient is along the presbyopic spectrum has a huge impact on the per-formance of simultaneous vision design multifocal contact lenses. One study evaluated the perfor-mance of three different soft multifocal designs (Acuvue Oasys for Presbyopia, Air Optix Aqua Multifocal, Biofinity Multifocal) on a group of low add (ages 40 to 45 years) patients (Vasudevan, 2013). No statistically significant differences in accommodative response, measured optical aber-rations, or in visual performance were found between the lenses.

However, with advancing presbyopia, there is greater likeli-hood that distance and near cor-rection will interfere with each other. This commonly requires biasing one eye for distance and the other for near to meet most


(Continued on page 56)

GP InsightsB Y E D W A R D S . B E N N E T T , O D , M S E D , F A A O

Dr. Bennett is assistant dean for Student Ser-vices and Alumni Relations at the University of Missouri-St. Louis College of Optometry and is executive director of the GP Lens Institute. You can reach him at [email protected].

HUsing Peroxide With GP Lenses

ydrogen peroxide disinfection offers benefits over other care systems. It consists of a 3% hydrogen peroxide solution, typically accompanied by a neutralizing tablet or disc. It has been found to be

safe, effective and preservative-free (Henry and Do, 2014). It produces a free radical superoxide that is toxic to microbes (Ward, 2013). And, whereas other systems often demonstrate incomplete effectiveness against Acantham-oeba, hydrogen peroxide has been shown to be effective against both the trophozoite (Hughes & Kilvington, 2001) and cyst (Mow-rey-McKee & George, 2007) forms of Acanthamoeba. It is also an effective cleaner due to its low ionic composition and hypotonic nature. It has the ability to lyse proteins and lipids from the lens surface while also penetrating mi-crobial biofilms (Gromacki, 2012).

Because the active disinfectant ingredient is hydrogen peroxide and not a preservative, it is a good system for both dry eye patients and those who are hypersensitive. All of these attributes also would be beneficial for individuals who aren’t particularly compliant with lens care.

Hydrogen Peroxide and GPs?However, do these benefits make hydrogen peroxide systems effec-tive for rigid gas permeable (GP) lenses? The answer is yes. Perox-ide’s ability to act as a disinfectant and remove protein buildup on GP lenses is advantageous (Gromacki and Ward, 2013). Be-

soak. It contains Pluronic 17R4 as a cleaning agent.

Both systems contain a plati-num disc attached to the lens case that will initiate the neutraliza-tion of hydrogen peroxide process immediately after insertion of the lens into the case, but the neutral-ization occurs at different rates for each solution.

B+L recommends that users discard the bottle and lens case 90 days after opening or after 35 uses, whichever comes first. Clear Care packaging recom-mends users dispose of the old case with each new purchase of Clear Care.

Regardless of the system used, a digital cleaning step is recom-mended by both manufacturers prior to disinfection.

Peroxide Works With GP LensesThe traditional use of hydrogen peroxide disinfection for GP wearers who have dry eye or pre-servative sensitivity is likely to increase as a result of both a new system indicated for GP lenses as well as the increasing popularity of scleral lens designs. With the benefits of effective lens disinfec-tion and cleanliness, hydrogen peroxide should be considered a viable — if not preferred — lens care option for your new and existing GP wearers. CLS


cause GP lenses don’t absorb a significant amount of the storage solution, patients can safely rinse this solution from the surface with a morning saline rinse prior to insertion.

Hydrogen peroxide is one of the preferred modalities in 48% of respondents to a scleral lens solution survey by Eef van der Worp for his I-Site newsletter (2010) and was the preferred mo-dality in 23% of respondents in a CL Today Quick Poll on scleral lens care (Nichols and Gromacki, 2013).

Peroxide Systems Available Presently there are two hydro-gen peroxide systems cleared by the FDA for use with GP lenses: PeroxiClear from Bausch + Lomb and Clear Care Cleaning & Disinfecting Solution from Alcon. Both are one-step systems.

In March 2014, Bausch + Lomb introduced the Peroxi-Clear hydrogen peroxide system indicated for use with all lenses, including GP lenses. This solution is a unique formula that contains Triple-Moist Technology, which claims to provide up to 20 hours of moisture according to Bausch + Lomb. PeroxiClear has a shorter neutralization cycle (4 hours) than Clear Care. The Clear Care peroxide system requires a 6-hour


Contact Lens Design & MaterialsB Y N E I L P E N C E , O D , F A A O

Dr. Pence serves as associate dean, Clinical and Patient Services, Indiana University School of Optometry in Bloomington, Ind. He is a con-sultant or advisor to B+L, Alcon, and Vistakon and has received research funding from AMO. You can reach him at [email protected].

ICharacteristics of a New Silicone Hydrogel Contact Lens

n the past few years, new silicone hydro-gel contact lens introductions have been lim-ited to the daily disposable category. In fact, it has been several years since a new monthly or

semi-monthly silicone hydrogel product had appeared, until the spring 2014 launch of the new Bausch + Lomb Ultra contact lens with MoistureSeal technology.

Bausch + Lomb Ultra contact lenses have several unique mate-rial innovations. Compared to hydrogel lenses, silicone hydrogel contact lenses are significant be-cause of the oxygen permeable characteristics of silicone. To achieve the goal of increased oxy-gen transmission and the related health benefits for the cornea that silicone allows, other less desir-able characteristics of silicone must be accounted for. Silicone is a stiffer, higher modulus material with very poor wetting charac-teristics. The lens design team is challenged to overcome these negative attributes in an attempt to achieve an ultimate balance of health, wettability, comfort, vi-sion, and handling.

One of the unique aspects of the Bausch + Lomb Ultra (sam-filcon A) material involves the make-up of the silicone compo-nent. Rather than having a single silicone material incorporated into the silicone hydrogel prod-uct, Bausch + Lomb Ultra utilizes a combination of three distinct

the monthly silicone hydrogel category. The Dk/t is 163 at the center of a -3.00 diopter lens, which has a center thickness of 0.07 mm. The lens is produced with a 14.2 mm diameter, and has an 8.5 mm base curve. The edge design shows a tapered, relatively thin profile.

The Bausch + Lomb Ultra contact lens employs aspheric optics designed to correct the av-erage spherical aberration of the eye, similar to other lenses made by the company.

Bausch + Lomb has introduced the lens as a monthly replacement contact lens. Currently, the FDA has granted clearance to Bausch + Lomb Ultra for daily wear. Power availability will be from +6.00 to –12.00 D, in 0.25D steps for most of that range, but 0.50D steps above –6.00D.

The result of polymer chemistry, manufacturing and lens design innovations, the Bausch + Lomb Ultra silicone hydrogel monthly replacement contact lens should be a welcome addition to the contact lens mar-ket. Achieving the desired balance of health, vision, comfort and handling attributes is not only the goal of contact lens manufactures, but of the practicing contact lens fitter as well. CLS

types of silicone. The lens takes advantage of slightly different attributes of the three silicone materials. By finding the optimal mix of three different silicones, the material is able to provide a balance of high oxygen transmis-sibility and low modulus.

The second significant innova-tion related to Bausch + Lomb Ultra contact lenses involves the polymerization process. In a unique two-phase curing process, the silicone components polym-erize first in the mold when sub-jected to specific radiant energy. This forms a basic structure or framework for the eventual sili-cone hydrogel contact lens.

In a time-delayed second phase, polyvinylpyrrolidone (PVP) is then polymerized through and around this silicone lattice-like framework. The lens designers tell us that this allowed significantly more PVP to be incorporated into the silicone hydrogel, which should result in enhanced moisture retention characteristics for the material.

The final result of the mate-rial and manufacturing science efforts is a 46% water content silicone hydrogel lens with one of the lowest modulus values in


Dry Eye Dx and TxB Y K A T H E R I N E M . M A S T R O T A , M S , O D , F A A O

Dr. Mastrota is secretary of the Ocular Surface Society of Optometry and center director at the New York office of Omni Eye Services. She is a stock shareholder of TearLab Corporation and a consultant or advisor to Alcon, Allergan, B+L, Nicox, OcuSoft and Sarcode Bioscience. Contact her at [email protected].

IOcular Surface and Tear Film in Contact Lens Discomfort

n the fall of 2013, the Tear Film and Ocular Surface (TFOS) Society published The TFOS International Workshop on Contact Lens Dis-comfort (CLD) report (Nichols et al, 2013). This

international consensus follows two prior workshops, the Dry Eye Workshop (DEWS) and the Meibomian Gland Dysfunction (MGD) Workshop.

These workshops constructed an evidence-based approach for evaluating their target subjects. And, equally important, they proposed direction for continued information and data gathering in areas showing promise for identi-fying the elusive mechanisms core to clinical dysfunctions.

Questions AnsweredThe CLD Workshop was charged with addressing the following concerns: Why do contact lens wearers develop discomfort? How is CLD defined? How can we classify it? Who gets CLD? How does CLD happen? How do we manage CLD? How do contact lens materials, designs, and care impact CLD? How do we design clinical trials to answer these questions?

Subcommittees of the CLD Workshop investigated how, or if, contact lens interactions with the ocular surface and tear film contributed to lens-wearing dis-comfort, or rather “adverse ocular sensation”—that is, dryness, irri-

compared with non-lens wearers. Thus, contact lens wear may re-sult in MGD.

Tear film changes occur with the introduction of a contact lens to the ocular surface. Consider that the presence of a contact lens on the eye divides the tear film into a pre- and postlens tear film, creating new ocular interfaces within the ocular environment. The direct biophysical impact of the resultant decreased tear film stability, increased tear evapora-tion rate, reduced tear film turn-over and tear ferning are associat-ed with CLD. (Tear ferning is the branching crystallization pattern of tear fluid once collected and dropped on a microscopy slide and allowed to dry; ferning is an indication of tear functionality).

Does contact lens wear cause dry eye or does dry eye cause contact lens discomfort? There is much to discover about the dynamic interplay of the ocular surface and a contact lens. The CLD Workshop report is a com-pendium of what we know and a guide to follow as we search for more answers in CLD and ocular surface disease. CLS


tation, discomfort, fatigue, and so on — during lens wear.

Findings Interestingly, in an evidence-based review, there was no signifi-cant association with morpholog-ic changes in the corneal epithe-

lium (barrier function, staining) or corneal hypoxia with CLD. Of note, the conjunctiva, both bulbar and marginal (the leading edge of the palpebral conjunctiva as it moves across the contact lens sur-face, or “lid-wiper”) proved to be a tissue more closely linked to the development of CLD.

Additionally, contact lens wear does appear to affect the morphology and function of the meibomian glands. Furthermore, the frequency of meibomian loss is higher in contact lens wearers

Does contact lens wear cause dry eye

or does dry eye cause contact lens

discomfort?


Contact Lens Care & ComplianceB Y M I C H A E L A . W A R D , M M S C , F A A O

Mr. Ward is an instructor in ophthalmology at Emory University School of Medicine and Director, Emory Contact Lens Service. He is a consultant/advisor to Alcon and B+L. You can reach him at [email protected].

PNew Option for Peroxide Disinfection

eroxiClear is a new entrant to our peroxide-based contact lens disinfectant armamentarium. It’s a one-step 3% hydrogen peroxide (H2O2)-based cleaning and disinfecting system, which

claims to keep lenses cleaner and moister for longer periods with complete disinfection and neu-tralization in a 4-hour time frame.

ChemistryPeroxiClear contains Bausch + Lomb’s Triple-Moist technology, which employs three moistur-izing ingredients: poloxamer 181, propylene glycol and carbamide. Poloxamer 181 is unique to this product. It’s a surfactant that per-sists on lens surfaces and helps to attract and spread moisture over the surface of the contact lens.

Propylene glycol (PG) is a surfactant, wetting agent and dis-persant and is a common compo-nent in artificial tears. PG mixes completely with water and can hold approximately 2.8 times its weight in water (Bausch + Lomb, Patent EP0969812A1, 2000).

Carbamide functions as both a moisturizing agent and a plat-inum-modulating agent (PMC) (Millard et al, 2014). As a PMC, it reversibly binds to the platinum on the neutralizing disc, slowing the initial rate of neutralization of hydrogen peroxide.

This process allows a higher concentration of peroxide over a longer time frame, which effec-

ing the free radical superoxide, which is toxic to DNA. Peroxides denature proteins, thus damaging necessary microbial cell structures (Ward, 2006).

The hydrogen peroxide in these systems must be neutralized prior to lens wear because unneu-tralized peroxide is toxic. A con-cern with any hydrogen peroxide disinfection product is the poten-tial for contamination of lenses stored in previously neutralized peroxide solution. Although hy-drogen peroxide systems have high antimicrobial efficacies at full strength, once neutralized, they become unpreserved aque-ous bathing solutions, capable of supporting microbial growth.

That said, peroxide systems work fine if used on a daily basis, They are approved for 7 days of storage, but patients should pay attention to the inside of the lens case cap as little or no dis-infection occurs on this surface. Patients can disinfect the cap by rinsing it with fresh peroxide.

Remember to instruct patients to always follow the instructions of each individual care system. CLS


tively strengthens the antimicro-bial activity of the system.

The platinum disc catalyzes the breakdown of H2O2 into oxygen and water. As this reac-tion proceeds the dynamics of the solution shift, allowing the carbamide to return to solution and lens surface, increasing avail-ability of peroxide molecules to interact with platinum disc neu-tralizing sites.

PeroxiClear has a disinfection and neutralization time of 4 hours. This 3% H2O2/platinum disc neutralization system claims 99.9% disinfection efficacy, which is consistent with other one step peroxide-based systems. Peroxi-Clear is preservative free.

Peroxide DisinfectantsHydrogen peroxide disinfecting systems offer antimicrobial effi-cacy without the use of preserva-tives. Microfiltered, stabilized and buffered 3% hydrogen peroxide is the disinfectant in peroxide-based systems, which are effective against a wide variety of organ-isms, such as bacteria, fungi (in-cluding spores and yeasts), viruses and some protozoa.

Hydrogen peroxide destroys pathogens by oxidation, creat-


REFERENCES: 1. A total of 300 eye care practitioners asked patients to use Biotrue. 811 self-identifi ed OPTI-FREE RepleniSH users used Biotrue for at least 3 days and responded to an onlinesurvey. 2. Results of U.S. in vitro study performed to evaluate the rate of release of wetting agents from various silicone hydrogel lens materials over a period of 20 hours. 3. Results of in vitro study following FDA/ISO stand�alone procedure for disinfecting products modifi ed with organic soil added to create a more rigorous test condition. Primary criteria for e� ective disinfection are defi ned as a reduction in the number of bacteria by a minimum of 3 logs (99.9%) and a reduction of mold and yeast by a minimum of 1 log (90%) within the recommended disinfection time. 4. Results from a 22-investigator, multi-site study of PeroxiClear™, with a total of 440 eligible subjects. Subjects were randomized to use either PeroxiClear™ or Clear Care for 3 months. Subjects completed performance surveys at 2-week, 1-month, 2-month, and 3-month visits. 5. Results from a 21-investigator, multi-site study of PeroxiClear™, with a total of 297 eligible subjects who were habitual Clear Care users. After 7 days of use, subjects completed an online survey. Consumers rated the performance of PeroxiClear™ across a range of attributes and compared the performance to their habitual Clear Care solution. 6. High-resolution/accurate-mass (HR/AM) mass spectrometry was used to detect and quantitate the relative amounts of surfactant retained on lenses from PeroxiClear™ and Clear Care solutions after 20 hours of wear. PureVision®2, ACUVUE OASYS, and AIR OPTIX AQUA lenses were soaked in solutions for 12 hours prior to patients wearing lenses for 20 hours. 7. Results of an ex vivo study measuring deposits on worn contact lenses to compare the clinical performance of PeroxiClear™ and Clear Care solutions. Lenses were worn daily for 1 month (silicone hydrogel and Group IV hydrogel lenses) or 3 months (gas permeable lenses). A total of 374 lenses were randomly selected for image analysis. Lenses were scored for mean density of deposits and percent coverage of deposits.

Distributed by Bausch + Lomb, a Division of Valeant Pharmaceuticals North America LLC, Bridgewater, N.J. © 2014 Bausch & Lomb Incorporated. ®/™ are trademarks of Bausch & Lomb Incorporated or its a ̈ liates. All other brand/product names are trademarks of their respective owners. PNS07302 US/BIO/14/0020

Exceptional Lens Care Solutions from

Exceed any of your patients’ needs

Multi-purpose Rigid gas permeable Peroxide

9 OUT OF 10 Prefer Biotrue®

over the leading multi-purpose solution1

#1 doctor recommended RGP brand*

The most advanced* peroxide

www.biotrue.com

Biotrue® Multi-Purpose Solution

• Works like your eyes with the same pH and lubricant they have naturally

• Provides up to 20 hours of moisture2

• Kills 99.9% of germs3

www.bausch.com/peroxiclear

PeroxiClear™ 3% Hydrogen Peroxide Cleaning and Disinfecting Solution

• Provides superior all-day comfort4-5*

• Keeps lenses cleaner** and moister for longer4-7*

• Delivers exceptional disinfection in only 4 hours

*Compared to Clear Care**Using ACUVUE ADVANCE and ACUVUE OASYS lenses

www.bausch.com/boston

Boston ADVANCE® Comfort Formula System• Enhanced wettability for exceptional comfort

Boston SIMPLUS® Multi-Action Solution

• Cleans, disinfects, conditions, and removes protein with

single-bottle convenience

Boston® Solution System• Excellent disinfection in a mild, gentle formula

* Compared to Clear Care *Symphony Health Solutions, data on fi le.

REFERENCES: 1. A total of 300 eye care practitioners asked patients to use Biotrue. 811 self-identifi ed OPTI-FREE RepleniSH users used Biotrue for at least 3 days and responded to an onlinesurvey. 2. Results of U.S. in vitro study performed to evaluate the rate of release of wetting agents from various silicone hydrogel lens materials over a period of 20 hours. 3. Results of in vitro study following FDA/ISO stand�alone procedure for disinfecting products modifi ed with organic soil added to create a more rigorous test condition. Primary criteria for e� ective disinfection are defi ned as a reduction in the number of bacteria by a minimum of 3 logs (99.9%) and a reduction of mold and yeast by a minimum of 1 log (90%) within the recommended disinfection time. 4. Results from a 22-investigator, multi-site study of PeroxiClear™, with a total of 440 eligible subjects. Subjects were randomized to use either PeroxiClear™ or Clear Care for 3 months. Subjects completed performance surveys at 2-week, 1-month, 2-month, and 3-month visits. 5. Results from a 21-investigator, multi-site study of PeroxiClear™, with a total of 297 eligible subjects who were habitual Clear Care users. After 7 days of use, subjects completed an online survey. Consumers rated the performance of PeroxiClear™ across a range of attributes and compared the performance to their habitual Clear Care solution. 6. High-resolution/accurate-mass (HR/AM) mass spectrometry was used to detect and quantitate the relative amounts of surfactant retained on lenses from PeroxiClear™ and Clear Care solutions after 20 hours of wear. PureVision®2, ACUVUE OASYS, and AIR OPTIX AQUA lenses were soaked in solutions for 12 hours prior to patients wearing lenses for 20 hours. 7. Results of an ex vivo study measuring deposits on worn contact lenses to compare the clinical performance of PeroxiClear™ and Clear Care solutions. Lenses were worn daily for 1 month (silicone hydrogel and Group IV hydrogel lenses) or 3 months (gas permeable lenses). A total of 374 lenses were randomly selected for image analysis. Lenses were scored for mean density of deposits and percent coverage of deposits.

Distributed by Bausch + Lomb, a Division of Valeant Pharmaceuticals North America LLC, Bridgewater, N.J. © 2014 Bausch & Lomb Incorporated. ®/™ are trademarks of Bausch & Lomb Incorporated or its a ̈ liates. All other brand/product names are trademarks of their respective owners. PNS07302 US/BIO/14/0020

Exceptional Lens Care Solutions from

Exceed any of your patients’ needs

Multi-purpose Rigid gas permeable Peroxide

9 OUT OF 10 Prefer Biotrue®

over the leading multi-purpose solution1

#1 doctor recommended RGP brand*

The most advanced* peroxide

www.biotrue.com

Biotrue® Multi-Purpose Solution

• Works like your eyes with the same pH and lubricant they have naturally

• Provides up to 20 hours of moisture2

• Kills 99.9% of germs3

www.bausch.com/peroxiclear

PeroxiClear™ 3% Hydrogen Peroxide Cleaning and Disinfecting Solution

• Provides superior all-day comfort4-5*

• Keeps lenses cleaner** and moister for longer4-7*

• Delivers exceptional disinfection in only 4 hours

*Compared to Clear Care**Using ACUVUE ADVANCE and ACUVUE OASYS lenses

www.bausch.com/boston

Boston ADVANCE® Comfort Formula System• Enhanced wettability for exceptional comfort

Boston SIMPLUS® Multi-Action Solution

• Cleans, disinfects, conditions, and removes protein with

single-bottle convenience

Boston® Solution System• Excellent disinfection in a mild, gentle formula

* Compared to Clear Care *Symphony Health Solutions, data on fi le.


Contact lens discomfort (CLD) is a frequently reported symptom of patients wearing con-tact lenses and a prima-

ry reason for contact lens “drop out” (Dumbleton et al, 2013; Richdale et al 2007; Young et al 2002). Reported rates of contact lens “drop out” range between 23-34% (Dumbleton et al, 2013; Richdale et al, 2007; Pritchard et al, 1999). To summarize, half of your contact lens patients experience frequent discomfort, and on average, one of every four drop out of lens wear entirely, which can significantly impact your practice bottom line. We practitioners who fit contact lenses may consider changing the patient’s lens material, replacement schedule, wearing time, lens care solution, add-ing additional therapy, or a combina-tion of the above as possible treatment options to appropriately address the patient’s needs. However, there is a lack of literature detailing the classifi-cation, definition, and etiology, which are needed for the appropriate treat-ment and management of CLD. Thus, the Tear Film and Ocular Surface Society (TFOS) conducted an Inter-

national Workshop on Contact Lens Discomfort to address topics related to CLD and provide an appropriate foundation for further research, diag-nosis, treatment, and management of CLD with an ultimate goal of keeping patients successful contact lens wear-ers. The Executive Summary along with the entire report can be found in the October 2013 issue of Investigative Ophthalmology & Visual Science (IOVS) (Nichols et al, 2013).

Defining Contact Lens DiscomfortTo provide a detailed description of the condition that can also be utilized for future work, the TFOS Workshop developed the following definition for CLD:

“Contact lens discomfort is a con-dition characterized by episodic or persistent adverse ocular sensations related to lens wear, either with or without visual disturbance, resulting from reduced compatibility between the contact lens and the ocular envi-ronment, which can lead to decreased wearing time and discontinuation of contact lens wear” (Nichols et al, 2013).

B y K a t h e r i n e M . B i c k l e , O D, M S a n d Ke l l y K . N i c h o l s , O D, M P H , P h D

Each year, patients in our practices are struggling with lens wear, and in some cases, dropping silently out of lens wear. How do we get to the bottom of this problem?

Contact Lens Discomfort Defined

C O N T A C T L E N S D I S C O M F O R T

Dr. Bickle is a Ph.D. student at The Ohio State University College of Optometry and is in private practice in Granville, OH. She is a con-sultant to Bausch + Lomb.

Dr. Nichols is Dean and Professor of the University of Alabama at Birmingham. In the past 12 months, she has been a consultant to Alcon, Allergan, Bausch + Lomb/Valeant, Insite, Kala and Nicox. She has received research support from Allergan and Sarode/Shire and has stock options in TearLab.


including the patient’s age, gender, medical history, and medications, onset and frequency of symptoms, previous and current lens material and care system(s). Important questions to determine where a patient is in the progression toward discomfort include to-tal wearing time and comfortable wearing time. Are both of these enough for the patient? If a patient has

tried every care system and many different lenses, he is at much higher risk of discontinuing contact lens wear. Lens replacement schedule, usage of topical eye drops or other therapies, compliance, and environ-mental concerns also can provide direction in craft-ing an appropriate management plan.

Even if a patient is symptomatic, there may be a lack of signs to correlate with these symptoms. Therefore, when treating and managing these pa-tients, relying on the patient’s symptoms is impor-tant as this can be the driving force for the patient ultimately choosing to continue with contact lens wear. Questionnaires such as the Contact Lens Dry Eye Questionnaire (Nichols et al, 2002), the Ocular Surface Disease Index (Schiffman et al, 2000), or the Standard Patient Evaluation of Eye Dryness survey (Ngo et al, 2013) may be useful tools to incorporate into your practice. Staff members can administer and grade these questionnaires to assist you in identifying or monitoring patients who may be at risk for CLD.

Contact Lens Materials, Design and Care There are many factors that we as practitioners con-sider when choosing an appropriate lens material, as-sessing the lens fit, and choosing a suitable lens care solution for our patients. Based upon current knowl-edge and studies reported in the literature, it is dif-

The Defintion and Classification Report classi-fied CLD into two main categories, discomfort re-lated to the “contact lens” and/or the “environment” (Nichols et al, 2013). The contact lens category is further separated into 4 subgroups, “contact lens ma-terial, contact lens design, contact lens fit and wear, and lens care,” while the four subgroups of environ-ment are “inherent patient factors, modifiable patient factors, ocular environment, and external environ-ment.” While some of these factors have been more thoroughly investigated or validated than others, it is necessary to develop an understanding of the role each of these factors has on CLD with future studies. Previous studies evaluating contact lenses that differ by only one factor, such as water content, have been lacking in the literature, in part due to the difficulty in separating material factors. Patient factors and environmental factors have been studied to some degree, although not in a systematic way. There is much work to be done.

By definition, CLD symptoms diminish or cease after contact lens removal. Thus, this workshop sum-mary was not focused on underlying dry eye in con-tact lens wearers. Reported symptoms from patients with contact lens dry eye may be similar to CLD, but these symptoms are present with and without contact lens wear, thus the terminology should not be used interchangeably.

A patient’s progression with CLD is also outlined within the report. First, an initial awareness of symp-toms and difficulty with lens wear (“strugglers”) can progress to reduced comfortable and total wear time, which can ultimately result in discontinuing contact lens wear permanently. Consider where your contact lens patients fall on this scale and how you can uti-lize your clinical expertise and the evidence-based approach of the CLD workshop to prevent them from dropping out of contact lens wear through early identification and appropriate management. The goal of successful contact lens wear should be paramount in today’s clinical practice.

Identifying Patients With Contact Lens DiscomfortWhile CLD symptoms can vary, patients will typi-cally report some type of dryness, irritation, fluctua-tion in vision, discomfort, or foreign body sensation after contact lens insertion, and these symptoms may increase in frequency and severity throughout the wear time. This cycle typically continues every day. Obtaining a thorough history from the patient is cru-cial with appropriate questions or factors to consider

Patients will typically report some type of dryness, irritation,

fluctuation in vision, discomfort, or foreign body sensation after

contact lens insertion. This cycle typically

continues every day.


lens discomfort. However, the lens edge design can impact a patient’s level of comfort and result in clini-cal signs. Further discussion on this later.

Although there is no true agreement on the opti-mal composition of a lens care solution in terms of improving comfort, patient education remains cru-cial. Patients must be instructed not only how to most effectively use their solution but also proper contact lens wearing and replacement schedules. Revisiting this issue with staff who routinely train patients can promote compliance.

Impact on the Ocular Surface and AdnexaWhile some corneal (hypoxia, stromal infiltrates, neovascularization, endothelial changes), conjuncti-

val (bulbar hyperemia), or limbal (limbal hyperemia) changes may lead to changes in your treatment and management of the patient, there have been no direct associations between these factors and contact lens discomfort (Efron et al, 2013). However, there ap-pears to be a stronger link with the bulbar conjunc-tival staining and “lid wiper” changes assessed with lissamine green (Guillon and Maissa, 2005; Korb et al, 2002; Yeniad et al, 2010). Although sodium fluo-rescein instillation may be more commonly used in clinical practice to assess corneal staining, tear break up time, etc., the use of lissamine green can provide valuable information related to the severity and pattern of conjunctival staining. Additionally, as reported in the literature, changes to the “lid wiper” area have also been related to CLD (Korb et al, 2002; Yeniad et al, 2010). However, debate exists on the exact etiology of lid wiper epitheliopathy (LWE), whether lens or other therapy changes impact LWE, and what impact these modifications will have on a patient’s symptoms.

Examination of the meibomian glands is also im-portant. While meibomian glands are frequently as-sociated with dry eye, there is evidence that contact lens wear can potentially negatively affect the func-

ficult to determine the true role that contact lens ma-terials and design (lubricity, surface treatments, water content, modulus, Dk/t, and so on) and lens care have on contact lens discomfort (Santodomingo-Rubido et al, 2006, Fonn and Dumbleton, 2003). This is not necessarily due to their lack of association with CLD but as a result of varying definitions, study designs, and the difficulty in changing and evaluating only one factor related to the lens design/material in typi-cal research or clinical settings (Jones et al, 2013). Only a manufacturer has the ability to control for in-dividual factors within a given material to assess the impact on CLD.

It is not surprising given this lack of ability to control factors independently that most factors men-

tioned above have shown no strong association with CLD in the literature. However, there is some recent preliminary support for lubricity being an impor-tant factor in CLD (Jones et al, 2013). Theoretically, a lens with a lower coefficient of friction provides a smoother interaction between the lens and the eyelid. Considering the number of times we blink each day, reducing friction makes sense clinically. It remains to be seen whether clinical findings such as lid wiper ep-itheliopathy, thought to be associated with mechani-cal friction, are reduced or eliminated with newer lens materials that offer lower coefficients of friction.

The true role of lens deposition and its impact on contact lens discomfort remain unknown, but this should not discourage practitioners from changing lenses, care solutions, or other therapies if lens depo-sition is resulting in other issues for the patient. Un-derlying dry eye or meibomian gland dysfunction are also considerations, and may impact the lens material selected for a patient as materials and coatings create differential deposition on lenses. While this may not directly correlate with CLD, it’s worth consideration.

Additionally, lens fits are assessed for corneal cov-erage, centration, and movement, but there is no true consensus on the impact of these factors on contact


The true role of lens deposition and its impact on contact lens discomfort remain unknown, but this should not discourage practitioners from changing

lenses, care solutions, or other therapies if lens deposition is resulting in other issues for the patient.


tion of the meibomian glands. Arita and coworkers have used infrared meibography to associate gland loss with years of lens wear (Arita et al, 2009). These studies will be useful in determining which comes first in this chicken-and-egg argument.

In summary, the meibomian glands and LWE have been shown in the literature to have a stronger con-nection to CLD than other areas of the ocular surface and adnexa (Henriquez and Korb, 1981; Korb et al, 2002). Lissamine green testing is quick and provides little to no discomfort to the patient while potentially providing valuable information as you’re managing a patient with contact lens discomfort. Further re-search investigating the association between CLD and the meibomian glands or LWE to better under-stand their role in CLD is worthwhile and needed.

Contact Lens Wear and the Tear Film A pre-and post-lens tear film is created after the ap-plication of a contact lens. This disruption of the tear film has been shown to negatively impact the evapo-ration rate and stability of the tear film, and these fac-tors have been associated with CLD (Fonn et al, 1999; Glasson et al 1999; Kojima et al, 2011). Despite these changes to the tear film that occur with contact lens insertion, there are successful contact lenses wearers, and thus, it is important to consider that there are multiple factors on the ocular surface that contribute to these changes and the patient’s symptoms, as well as factors that determine success (Craig et al, 2013). In the future, we believe we will continue to see lens materials and care systems designed to have minimal impact on the normal tear film and even help prevent lens material dehydration. This may result in better stability of the tear film with lens wear, which will provide practitioners with additional options to re-duce CLD symptoms in patients while also providing better and more stable vision.

Treating and Managing Your Patients with CLD Although a contact lens patient may report symp-toms of discomfort, we must also consider that there are other potential non-contact lens-related factors or etiologies of this discomfort. It is important to ap-propriately treat and manage these factors, which can help you determine whether the discomfort is truly contact lens-related (Papas et al, 2013).

The CLD report reviewed the existing literature surrounding management of discomfort with con-tact lens wear. While the terminology used in defin-ing subjects for the multitude of studies varied, some

common themes emerged (Papas et al, 2013). After treating any other underlying conditions, switching the contact lens material may be chosen as a treatment option. In a rigid lens patient, consider changing to a lens with a steeper base curve in a soft lens patient and using a larger diameter lens as this may provide some relief of symptoms. Additionally, switching to a

daily disposable contact lens may provide some im-provement in CLD. (Solomon et al, 1996; Cho and Boost, 2013).

While there are some therapies that have been uti-lized in treatment of dry eye such as artificial tears, fish oil, topical medications, such as cyclosporine A (Kim et al, 2009; Rao, 2010), topical azithromycin (Opitz DL and Tyler KF, 2011; Luchs 2008), and ste-roids (Pflugfelder et al, 2004), punctal plugs (Ervin et al, 2010), and avoiding certain environments, such as low humidity, and so on (Gonzalez-Garcia MJ, 2007), further research is needed to determine the benefits of these treatments with CLD.

Conclusion While we still have much to learn about CLD, we now have a definition and classification scheme that provides a foundation on which future research can be focused to help us better understand this condi-tion through the CLD reports (Nichols et al, 2013). Practitioners, researchers, and companies are con-stantly striving to develop and provide new contact lens materials, lens care solutions, and other treat-ment options for our patients to reduce or even bet-ter prevent symptoms associated with contact lens discomfort. These efforts will ultimately result in more of our patients being successful contact lens wearers. CLS

The meibomian glands and lid wiper epitheliopathy

have been shown in the literature to have a stronger connection to CLD than other areas of the ocular surface

and adnexa.



References 1. Dumbleton K, Wood CA, Jones LW, Fonn D. The impact of

contemporary contact lenses on contact lens discontinuation. Eye Contact Lens. 2013; 39(1): 93-99.

2. Richdale K, Sinnott LT, Skadahl E, Nichols JJ. Frequency of and factors associated with contact lens dissatisfaction and discontinuation. Cornea. 2007; 26(2): 168-174.

3. Young G, Veys J, Pritchard N, Coleman S. A multi-centre study of lapsed contact lens wearers. Ophthalmic Physiol Opt. 2002; 22(6): 516-527.

4. Pritchard N, Fonn D, Brazeau D. Discontinuation of contact lens wear: a survey. Int Contact Lens Clin. 1999; 26(6): 157-162.

5. Nichols JJ, Willcox MDP, Bron AJ, et al. The TFOS Inter-national Workshop on Contact Lens Discomfort: Executive Summary. Invest Ophthalmol Vis Sci. 2013; 54(11): TFOS7-13.

6. Nichols KK, Redfern RL, Jacob JT, et al. The TFOS Interna-tional Workshop on Contact Lens Discomfort Report of the Definition and Classification Subcommittee. Invest Ophthal-mol Vis Sci. 2013; 54(11): TFOS14-19.

7. Nichols JJ, Mitchell GL, Nichols KK, Chalmers R, Begley C. The performance of the contact lens dry eye questionnaire as a screening survey for contact lens-related dry eye. Cornea. 2002; 21(5): 469-75.

8. Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000; 118(5): 615-21.

9. Ngo W, Situ P, Keir N, Korb D, Blackie C, Simpson T. Psy-chometric properties and validation of the Standard Patient Evaluation of Eye Dryness questionnaire. Cornea. 2013; 32(9): 1204-1210.

10. Santodomingo-Rubido J, Wolffsohn JS, Gilmartin B. Changes in ocular physiology, tear film characteristics, and symptomatology with 18 months silicone hydrogel lens wear. Optom Vis Sci. 2006; 83(20): 73-81.

11. Fonn D, Dumbleton K. Dryness and discomfort with silicone hydrogel contact lenses. Eye Contact Lens. 2003; 29(suppl 1): S101-S104; discussion S115-S118, S192-194.

12. Jones L, Brennan NA, Gonzáles-Méijome J, et al. The TFOS International Workshop on Contact Lens Discomfort: Report of the Contact Lens Materials, Design, and Care Subcommittee. Invest Ophthalmol Vis Sci. 2013; 54(11): TFOS37-TFOS70.

13. Efron N, Jones L, Bron AJ, et al. The TFOS International Workshop on Contact Lens Discomfort: Report of the Contact Lens Interactions With the Ocular Surface and Adnexa Subcommittee. Invest Ophthalmol Vis Sci. 2013; 54: TFOS98-TFOS122.

14. Guillon M, Maissa C. Bulbar conjunctival staining in contact lens wearers and non lens wearers and its association with symptomatology. Cont Lens Anterior Eye. 2005; 28(2): 67-73.

15. Korb DR, Greiner JV, Herman JP, et al. Lid-wiper epitheli-opathy and dry-eye symptoms in contact lens wearers. CLAO J. 2002; 28(4): 211-216.

16. Craig JP, Willcox MDP, Argüeso P, et al. The TFOS Interna-tional Workshop on Contact Lens Discomfort: Report of the Contact Lens Interactions With the Tear Film Subcommit-tee. Invest Ophthalmol Vis Sci. 2013; 54(11): TFOS123-156.

17. Yeniad B, Beginoglu M, Bilgin LK. Lid-wiper epitheliopathy in contact lens users and patients with dry eye. Eye Contact Lens. 2010;36(3):140-143.

18. Arita R, Itoh K, Inoue K, Kuchiba A, Yamaguchi T, Amano S. Contact lens wear is associated with decrease of meibomian glands. Ophthalmology. 2009; 116(30):379-384.

19. Henriquez AS, Korb DR. Meibomian glands and contact lens wear. Br J Ophthalmol. 1981;65(2)108-111.

20. Fonn D, Situ P, Simpson T. Hydrogel lens dehydration and subjective comfort and dryness ratings in symptomatic and asymptomatic contact lens wearers. Optom Vis Sci. 1999; 76(10): 700-704.

21. Glasson MJ, Hseuh S, Willcox MD. Preliminary tear film measurements of tolerant and non-tolerant contact lens wearers. Clin Exp Optom. 1999; 82(5): 177-181.

22. Kojima T, Matsumoto Y, Ibrahim OM, et al. Effect of controlled adverse chamber environment exposure ton tear functions in silicon hydrogel and hydrogel soft contact lens wearers. Invest Ophthalmol Vis Sci. 2011; 52(12): 8811-8817.

23. Papas EB, Ciolino JB, Jacbos D, et al. The TFOS Interna-tional Workshop on Contact Lens Discomfort: Report of the Management and Therapy Subcommittee. Invest Ophthalmol Vis Sci. 2013; 54(11): TFOS183-TFOS203.

24. Solomon OD, Freeman MI, Boshnick EL, et al. A 3-year prospective study of the clinical performance of daily dispos-able contact lenses compared with frequent replacement and conventional daily wear contact lenses. CLAO. 1996; 22(4): 250-257.

25. Cho, P, Boost MV. Daily disposable lenses: The better alter-native. Cont Lens Anterior Eye. 2013; 36(1): 4-12.

26. Kim EC, Choi JS, Joo CK. A comparison of vitamin a and cyclosporine a 0.05% eye drops for treatment of dry eye syndrome. Am J Ophthalmol. 2009; 147(2): 206-213.

27. Rao SN. Topical cyclosporine 0.05% for the prevention of dry eye disease progression. J Ocul Pharmacol Ther. 2010; 26(2): 157-164.

28. Opitz DL, Tyler KF. Efficacy of azithromycin 1% ophthalmic solution for treatment of ocular surface disease from poste-rior blepharitis. Clin Exp Optom. 2011; 94(2): 200-206.

29. Luchs J. Efficacy of topical azithromycin ophthalmic solution 1% in the treatment of posterior blepharitis. Adv Ther. 2008; 25(9): 858-870.

30. Pflugfelder SC, Maskin SL, Anderson B, et al. A randomized, double-masked, placebo-controlled, multicenter comparison of loteprednol etabonate ophthalmic suspension, 0.5%, and placebo for treatment of keratoconjunctivitis sicca in patients with delayed tear clearance. Am J Ophthalmol. 2004; 138(3): 444-457.

31. Ervin AM, Wojciechowski R, Schein O. Punctal occlusion for dry eye syndrome. Cochrane Database Syst Rev. 2010; 9: CD006775.

32. Gonzalez-Garcia MJ, Gonzalez-Saiz A, De la Fuente B, et al. Exposure to a controlled adverse environment impairs the ocular surface of subjects with minimally symptomatic dry eye. Invest Ophthalmol Vis Sci. 2007; 48(9): 4026-4032.

US/ZUS/14/0135


During thousands of blinks each day, a con-tact lens wearer’s eye-lid slides across the surface of the contact

lens. Spreading and maintaining the tear film across the surface of the lens between each blink is important in providing a smooth, slippery surface for reducing friction, sustaining the integrity of epithelial cells, and main-taining quality optics. Alterations in the tear film lead to eye complaints and can have a variety of causes in-cluding environmental factors such as low relative humidity or high room temperature, demanding task content such as high demand tasks that reduce blinking and increases exposed sur-face area, and individual factors such as blinking anomalies and contact lens use (Wolkoff et al, 2005).

The wearing of the contact lens on the surface of the eye alters the integrity of the tear film and changes the evaporation rate (Tomlinson et al, 1982; Korb, 1994; Guillon et al, 2008). Between blinks, the rapid evaporation results in tear film break-up that leads to increases in the local osmolarity of

the tear film (King-Smith et al, 2008) Increased tear film osmolality that re-sults from tear film thinning (evapo-ration or dewetting) is believed to be the cause of contact lens–related dry eye (Nichols, 2006). Today, contact lens wearers spend greater amounts of time using digital devices. To fill the void in the market for a contact lens that can meet the changing demands of patients in an increasingly screen-centric world, new approaches to ma-terial development are required.

Hydrogel contact lenses have poly-mer networks with varying water-binding characteristics. An effective barrier that retards the evaporation of the tear film is important for a slow tear film thinning rate. A long stand-ing challenge of silicone hydrogel materials has been associated with the hydrophobic nature of silicone. The inclusion of silicone into contact lens materials improves the oxygen per-meability of the material; however, increased levels of silicone result in increased hydrophobic properties of the bulk and surface chemistry for the lens material. As contact lens material science advanced, methods to make

By Katarzyna Wygladacz, MS, PhD; Daniel Hook, BS, MS, PhD; Robert Steffen, OD, MS & Will iam Reindel , OD, MS

Advanced contact lens materials and manufac-turing process deliver exceptional comfort.

Breaking the Cycle of Discomfort

N E W C O N T A C T L E N S

Dr. Steffen is the director of Clinical Affairs at Bausch + Lomb, a division of Valeant Pharmaceuticals.

Dr. Reindel is the Medical Director for Bausch + Lomb Canada.

Dr. Wygladacz is a Senior Research Scientist in Vision Care R&D at Bausch + Lomb, a division of Valeant Pharma-ceuticals International.


Dr. Hook is a Senior Principal Scientist at Valeant Pharma-ceuticals International, Inc. and Group Leader of the Structural and Surface Science Group within Bausch + Lomb.



chain silicone provides low modulus while the short chain silicones provide the majority of oxygen trans-port capability and structural integrity (for great han-dling characteristics).

In Phase 2 of MoistureSeal technology, polyvinyl-pyrrolidone (PVP), a humectant that is highly solu-ble in water, physiologically compatible, non-toxic, essentially chemically inert, temperature-resistant, pH-stable, non-ionic, and colorless is permanently entangled throughout the silicone matrix. PVP is a very hydrophilic compound that is frequently used in medicine, pharmaceutical technology, and cosmetics.(Folttmann et al, 2008). In fact, PVP has been used in another silicone hydrogel contact lens (senofilcon A) successfully.

While other lens manufacturers start with fully formed, large PVP molecules and then add silicone (Figure 1 A), MoistureSeal technology starts with the silicone backbone and polymerizes PVP in-situ around and throughout the silicone matrix (Figure 1 B). This process of “growing” the PVP from its molecular building blocks maximizes the utilization of PVP and results in significantly more PVP (4x as much of the wetting agent) than the silicone hydrogel lens material, senofilcon A. Importantly, the manu-facturing method that starts with fully formed PVP molecules cannot achieve the same concentration of PVP capable through MoistureSeal technology with-out sacrificing optical clarity of a lens due to phase separation of the PVP and silicone components. Only MoistureSeal technology allows for 4x more PVP in Bausch + Lomb Ultra contact lenses while maintain-ing optical clarity (Hoteling et al, 2014).

The water-loving polymer PVP is grown perma-nently around the silicone matrix in order to “hide” the hydrophobic silicone and to hold water through-out the bulk and at the surface of the lens. The PVP

silicone hydrogels more wettable progressed from modification of the surface with plasma treatments to adjusting the bulk chemistry of the material by adding wetting agents. In parallel, advancements in manufacturing capability were needed to compliment new materials to help ensure the lens is biocompat-ible and stable over a designated period of lens wear and lens care.

Unique Chemistry & Polymerization ProcessTo dramatically improve the effects of material and surface interaction, more complex strategies must be applied. This includes development of materials that withstand a range of user conditions and refinement of designs and geometries that minimize the impact of friction and wear. MoistureSeal technology, as part of the Bausch + Lomb Ultra contact lens material (samfilcon A), represents a significant achievement in integrating novel material chemistry and a two-phase manufacturing process to produce a unique silicone hydrogel lens designed to address the cycle of dis-comfort many wearers encounter each day and en-hance the overall lens wearing experience particularly at the end of the day.

MoistureSeal technology uses a unique reaction sequence that starts with the formation of a silicone matrix (with high Dk/t and low bulk modulus) fol-lowed by the time-delayed addition of internal, per-manent wetting agents to drive water content and surface wettability. In Phase 1 of the polymerization process, a unique combination of long and short chain silicone polymers creates a flexible silicone ma-trix with channels for oxygen transmission. The long

Figure 1. Different approaches for PVP entanglement: (A) Fully formed PVP integration with silicone (B) PVP grown around a silicone backbone via MoistureSeal Technology resulting in 4x more PVP.

A

PVPSi

B

PVPSi


in Bausch + Lomb Ultra contact lenses brings high water and wettability everywhere on the lens and not just at its surface. MoistureSeal technology also helps Bausch + Lomb Ultra contact lenses retain this high level of water throughout the day.

Surface Wetting and FrictionA wettable contact lens surface is essential to reduce friction and surface deposition and to improve optical quality and comfort. Two common assessments used to evaluate contact lenses at the surface involve mea-suring wetting angles and coefficients of friction. These assessments provide insights regarding the interactions between the lens, the tears, and the eyelid when the lenses are worn. When silicone’s hydrophobic struc-ture is more prominent at the surface of the lens, the contact angle and coefficients of friction values are higher (Read et al, 2011; Jacob, 2013). Polymer chemistry and manu-facturing processes, such as MoistureSeal technology play an important role in mask-ing the silicone structure for improved wetting.

Captive bubble contact angles were collected for the Bausch + Lomb Ultra, Air Optix Aqua (Al-con), Oasys (Vistakon), Biofinity (CooperVision) and Dailies Total1 (Alcon) silicone hydrogel lenses in order to assess and compare wettability. To remove components of the packaging solution from the sam-ples, lenses were rinsed in HPLC grade water prior to testing. Lenses were placed onto a curved sample holder and submerged into a quartz cell filled with HPLC grade water. Advancing and receding captive bubble contact angles were collected for each silicone hydrogel lens type.

The advancing angle is believed to represent the ability of the tear film to fill in dry patches result-ing from the breakup of tears, while the receding angle provides insight on the integrity of the interac-tion between the surface and the tear (Cheng et al, 2004). A contact angle of 0° indicates complete wet-ting, values between 0° and 90° indicate the surface is wettable to varying degrees, and values above 90° indicate the surface is not wettable. Advancing and receding contact angle measures indicated surface wetting was similar between Bausch + Lomb Ultra, Air Optix Aqua, Oasys, Biofinity and Dailies Total1 lenses (Figure 2 A).

Blinking is essential for maintaining a healthy ocu-lar surface and clarity of vision. The blink cycle in-cludes a fast phase during closure and a slow phase as the eye reopens (Kwon et al, 2013). As the eye-


lid moves across an opposing surface, it encounters resistance. Friction forces of Bausch + Lomb Ultra, Air Optix Aqua, Oasys, Biofinity and Dailies To-tal1 contact lens materials were investigated using a novel measurement technique that mimics the ap-plied pressure, sliding speeds encountered by a con-tact lens on the human eye, and controls for variables such as temperature and the surface area of lens and interface interaction.

Coefficient of friction measurements were per-formed using a rheometer outfitted with specially

designed tooling to hold and rub a contact lens im-mersed in borate buffered saline at 25°C. Static fric-tion was taken as a measure of friction at the start of the blink phase. Fast and slow kinetic friction was tak-en as measurements during a constant rotation speed test to model friction encountered during lid closure and opening, respectively. Measurements were made using samples of each contact lens either directly out of the package or after being worn on-eye for 4 hours. Forces applied to the lenses in this study mim-icked eyelid pressure to be more representative of an in-vivo environment compared to previous studies. The method is highly reproducible and controlled. Methods such as glass ramp techniques that lack stan-dardization when comparing different lens materials, specifically the glass ramp method does not control the speed of the lens across the control surface, nor does it quantify the distance that a lens needs to move down the ramp to achieve constant speed. Constant speed is a critical variable used to accurately measure friction between two surfaces. Additionally, the glass ramp test does not control for the force (or load) applied to the lens since the surface area of lens mate-rial exposed to the glass may vary from lens to lens. Furthermore, this method cannot discern between low versus high-speed kinetic friction, which may be important with respect to the blink phase. All of these factors may lead to potentially biased outcomes when comparing different contact lenses when measuring coefficient of friction using a glass ramp test.

During contact lens wear, friction and wearing down of

the surface are undesirable characteristics that can impact

the patient experience.


Mean static and kinetic friction results measured on a rheometer are presented for unworn (out of pack) and worn lenses (Figure 2 B-D). Friction at the initiation of movement was similar for all materials out of the package, except Dailies Total1, which was significantly higher than the other lenses (Figure 2B). After wear, the static friction measure indicated the Air Optix lens and Dailies Total1 had greater resistance. For fast kinetic measures of friction (Figure 2C), the Air Optix lens also demonstrated greater resistance out of package and after wear, while the Bausch + Lomb Ultra, Oasys, Biofinity, and Dailies Total1 lenses showed low friction. The slow kinetic friction measurements demonstrated that all materials have low friction during this phase of the blink cycle (Figure 2D).

Bausch + Lomb Ultra lenses demonstrated low co-efficient of friction regardless of the simulated blink speed and performed very consistently even after 4 hours of wear. The high level of wettability and low friction that MoistureSeal technology provides may improve the overall wearing experience of patients.

Surface Smoothness & IntegrityDuring contact lens wear, friction and wearing down of the surface are undesirable characteristics that can impact the patient experience. A smooth, du-rable surface is essential for spreading the tear film, reducing friction, and providing precision optics. MoistureSeal technology delivers a lens that with-stands the rigors of a planned replacement lens wear schedule. To demonstrate the smoothness and dura-bility of the Bausch + Lomb Ultra lens surface, Atom-ic Force Microscopy (AFM) and X-ray Photoelec-tron Spectroscopy (XPS) were used to evaluate the morphology, roughness, and elemental composition of new (unworn) Bausch + Lomb Ultra, Oasys, Bio-finity, and Air Optix Aqua contact lenses (Wygladacz et al, 2014). The impact of a lens care regimen on surface characteristics was simulated by performing rub/rinse cycles using renu fresh multi-purpose so-lution (30 cycles for Bausch + Lomb Ultra, Biofinity, and Air Optix Aqua; 15 cycles for Oasys). The AFM assessment provided morphology and surface rough-ness information and the XPS evaluations provided insights regarding elemental changes at the sur-face. Mean surface roughness was compared using a t-test between new lenses directly out of the blister to lenses of the same brand/type after simulated wear cycling (p-value <0.05 was considered significant).

Figures 3 A and B illustrate the surface smooth-ness of an unworn Bausch + Lomb Ultra lens,

Figure 2. Surface wettability characteristics. (A) Contact Angle (B) Static Coefficient of Friction (C) Fast Kinetic Coefficient of Friction (D) Slow Kinetic Coefficient of Friction.

(B)

Static Coefficient of Friction

n Out of Package n After 4h Wear

Bausch + LombUltra

Oasys Biofinity Air Optix Aqua Total1

10.90.80.70.60.50.40.30.20.1

0

(D)

Slow Kinetic Coefficient of Friction


Bausch + LombUltra


10.90.80.70.60.50.40.30.20.1

0

(C)

Fast Kinetic Coefficient of Friction


Bausch + LombUltra


0.90.8

0.7

0.6

0.5

0.40.30.20.1

0

(A)

Contact Angle


Bausch + LombUltra


9080

70

60

50

40302010

0




A) Bausch + Lomb Ultra - new

RMSANT (fresh) = 2.6 ± 0.3

B) Bausch + Lomb Ultra - cycled

RMSANT (cycled) = 3.0 ± 1.0 nm

C) Oasys - new

RMSANT (fresh) = 2.3 ± 0.4 nm

D) Oasys - cycled


E) Biofinity - new


F) Biofinity - cycled


H) Air Optix Aqua - cycled


G) Air Optix Aqua - new


Figure 3. AFM surface topography images (40 x 40 μm) of new (A) and cycled (B) Bausch + Lomb Ultra lens surfaces, new (C) and cycled (D) Oasys lens surfaces, new (E) and cycled (F) Biofinity surfaces, and new (G) and cycled (H) Air Optix Aqua lens surfaces.

and the durability of the Bausch + Lomb Ultra lens surface that was unaffected by 30 rub/rinse cycles with an MPS (p=0.145). In addition, the AFM re-sults confirmed the deposition resistance properties of the samfilcon A material as there were no atomic element differences between new and cycled

Bausch + Lomb Ultra contact lenses. The Oasys lenses demonstrated a visible change in roughness (Figure 3 C and D) with completion of 15 rub/rinse cycles (p<0.005). The AFM topography images for new and cycled Biofinity contact lenses showed a sig-nificant change in surface roughness (p<0.005). New Biofinity lenses had randomly distributed rough and tall domains that were removed and left “pockets” in the surface with rub/rinse cycling (Figures 3 E and F). The AFM topography images of new and cycled Air Optix Aqua lenses demonstrated that the plasma-coated surface was also altered by the 30 rub/rinse cycles (Figure 3 G and H) (p<0.005). The numerous cracks on the surface of cycled Air Optix Aqua lenses resulted in significantly higher concentrations of sili-cone being detected with the XPS elemental analysis.

The surface analyses demonstrated that even a gentle lens care system can have an impact on the surface morphology and exposure of atomic elements associated with non-wetting chemistry. Oasys, Air Optix Aqua and Biofinity lenses demonstrated statis-tically significant changes in surface roughness with 15 (Oasys) or 30 (Air Optix Aqua and Biofinity) rub/rinse cycles. The Bausch + Lomb Ultra lenses dem-onstrated no statistically significant changes in sur-face morphology, roughness, or elemental composi-tion after simulating 1 month of wear.

SummaryToday, new knowledge gained from advances in mate-rials chemistry and manufacturing processes enables designers to achieve significant improvements in con-tact lens characteristics. With each blink, it is essential that the tear film is distributed and maintained across the surface of the lens. To enhance the lens wearing

experience, a lens must provide a smooth, slippery surface for reducing friction, sustaining the integrity of epithelial cells, and maintaining quality optics. The lens performance must be sustained through varied environmental conditions, during diverse tasks per-formed by the contact lens user and over the planned replacement period. The combined wetting, friction, durability, dehydration and vision quality testing con-firm that the Bausch + Lomb Ultra contact lenses with MoistureSeal technology can provide an improved wearing experience for the contact lens wearer. CLS

References1. Cheng LS, Muller J, Radke CJ. Wettability of silicone-hydro-

gel contact lenses in the presence of tear-film components. Curr Eye Res 2004;28(2):93-108.

2. Folttmann H, Quadir A. Polyvinylpyrrolidone (PVP) – One of the Most Widely Used Excipients in Pharmaceuticals: An Overview. Drug Delivery Technology 2008;8(6):22-27.

3. Guillon M, C. Maissa C. Contact lens wear affects tear film evaporation. Eye Contact Lens 2008;34(6): 326-330.

4. Hoteling A, Nichols W, Harmon P, Hook D, Nunez I. PVP content of a silicone hydrogel material with dual phase polym-erization processing. American Optometric Association Annual Meeting; 2014, Philadelphia, PA.

5. Jacob JT. Biocompatibility in the development of silicone-hydrogel lenses. Eye Contact Lens 2013;39(1):13-19.

6. King-Smith PE, Nichols JJ, Nichols KK, Fink BA, Braun RJ. Contributions of evaporation and other mechanisms to tear film thinning and break-up. Optom Vis Sci 2008;85(8):623-630.

7. Korb DR. Tear film-contact lens interactions. Adv Exp Med Biol 1994;350:403-410.

8. Kwon KA, Shipley RJ, Edirisinghe M, et al. High-speed cam-era characterization of voluntary eye blinking kinematics. J R Soc Interface 2013;10(85):20130227.

9. Nichols JJ, Sinnott LT. Tear film, contact lens, and patient-related factors associated with contact lens-related dry eye. Invest Ophthalmol Vis Sci 2006;47(4):1319-1328.

10. Read ML, Morgan PB, Kelly JM, Maldonado-Codina C. Dynamic contact angle analysis of silicone hydrogel contact lenses. J Biomater Appl 2011;26(1): 85-99.

11. Tomlinson A, Cedarstaff TH. Tear evaporation from the hu-man eye: the effects of contact lens wear. J Br Contact Lens Assoc 1982;5:141-150.

12. Wolkoff P, Nojgaard JK, Troiano P, Piccoli B. Eye complaints in the office environment: precorneal tear film integrity influenced by eye blinking efficiency. Occup Environ Med 2005;62(1):4-12.

13. Wygladacz KA, Merchea M, Hook D. Comparative Surface Smoothness Durability of a Novel Silicone Hydrogel Mate-rial. Association for Research in Vision and Ophthalmology; 2014 annual meeting.

Bausch + Lomb Ultra and MoistureSeal are trademarks of Bausch & Lomb Incorporated or its affiliates. All other brand/product names are trademarks of their respective owners.

US/ZUS/14/0148


With each blink, it is essential that the tear film is distributed and maintained across the surface of the lens.


Break the Cycle of Discomfortfor unsurpassed comfort & vision all day1

See what happens when eye care professionals wear them for the first time at www.BLUltra.com

™

REFERENCE: 1. Results from a 22-investigator, multi-site study of Bausch + Lomb ULTRA® contact lenses with MoistureSeal® technology, on 327 current silicone hydrogel lens wearers. After 7 days of wear, subjects completed an online survey. Subjects rated performance across a range of attributes. Preference comparisons represent only those subjects expressing a preference. Ratio is based on the average across the silicone hydrogel lenses represented in the study. Bausch + Lomb ULTRA and MoistureSeal are trademarks of Bausch & Lomb Incorporated or its affiliates. All other product/brand names are trademarks of their respective owners. © 2014 Bausch & Lomb Incorporated. US/ZUS/14/0128

“It’s like wearing nothing.” —Dr. Greg Usdan, Memphis, TN


For over a decade, there have been dramatic changes in materials and design of soft contact lens-es. Clinical performance

advancements were typically led by advancements in polymer and surface chemistry and lens design characteris-tics. Examples include the integration of silicone into hydrogel materials to increase oxygen transmis-sibility, enhanced surface treatments with plasma or internal wetting agents to improve comfort, and lens design advances to im-prove vision.

Over this same period, there have been dramatic changes in the way we use our eyes with digi-tal display devices. The types and use of devices with smaller screen sizes have increased, where

55% of American adults report hav-ing a smartphone, 42% own a tablet computer, and 32% own an e-reader, Figure 1 (Pew Research, 2014). These devices are designed for reading and use at close range that result in the eyes constantly refocusing and re-positioning to process content. With increased concentration associated with visual tasks on digital devices,

B y R o b e r t S t e f f e n , O D , M S ; M o h i n d e r M . M e r c h e a , O D , P h D , M B A ; M a r j o r i e J . R a h , O D , P h D , & W i l l i a m R e i n d e l , O D , M S

New technology aims to make lens wear more comfortable despite increased digital viewing.

Clinical Performance of Samfilcon A Silicone Hydrogel Contact Lenses

N E W P R O D U C T


Dr. Reindel is the Medical Director for Bausch + Lomb Canada.

Dr. Rah is Senior Manager, Medical Affairs Pharma-ceuticals & Vision Care at Bausch + Lomb.

Dr. Merchea is former Executive Director, Head of Medical Affairs, Vision Care at Bausch + Lomb.

Figure 1. Changes in digital display device ownership.

100

80

60

40

20

02009 2010 2011 2012 2013 2014

Desk/Laptop Computer SmartphoneeReader Tablet/Computer


control these variables independently as they can al-ter polymer formulations and lens designs and then evaluate the clinical impact of each variable. Not surprisingly, an extensive review of the literature re-vealed that there are few proven links between con-tact lens discomfort and factors related to current

contact lens material, the lens design, or the care system (Jones et al, 2013). Simi-larly, a thorough review of the research associated with the tear film indicated that no single biophysical component could be singled out as responsible for discomfort (Craig et al, 2013). However, in considering other biophysical interac-tions, meibomian gland dysfunction and lid wiper epitheliopathy demonstrated the strongest link to contact lens dis-comfort (Efron et al, 2013).

In a survey of over 800 contact lens wearers, 72% indicated they would be very or quite disappointed if they could

no longer wear their contact lens (Gallup, 2013). Therefore, to maintain patient satisfaction with the care provided, it is important for eye care practitio-ners to help patients continue with their favored vi-sion correction. While a comprehensive assessment and intervention commonly occurs when a patient expresses dissatisfaction, the introduction of new technology offers practitioners the opportunity to address common complaints or provide patients with a more successful experience.

Before adopting new technology eye care prac-titioners will typically ask about its effectiveness in the real world. By allowing wide patient selection criteria, data collected in a “real world” evaluation captures clinically important information relevant to a particular population or treatment. Real world clinical evaluations can broaden knowledge of patient outcomes and can capture valuable, real-time patient data that is not present in controlled clinical trials. The purpose of this study was to evaluate the per-formance of the Bausch + Lomb Ultra contact lenses with MoistureSeal technology and advanced aspheric optics when worn by experienced silicone hydrogel contact lens wearers.

Study DesignThis was a prospective, single arm, open-label clini-cal study. Independent eye-care practitioners from 22 investigational sites enrolled patients. Institutional review board approval was obtained for the study, and patients signed an informed consent form. To be

blink rates decrease on average from 15 to 5 blinks per minute, while the number of incomplete blinks and tear film break-up time increases (Cardona et al, 2011; Chu et al, 2014; Himbaugh et al, 2009; Jansen et al, 2010; Patel et al, 1991; Portello et al, 2013).This in turn may lead to increased lens dehydration

and symptoms of dryness or discomfort. Overall, the digital technologies we routinely use can result in significant challenges for contact lens wearers.

While the advances in contact lens materials and designs are intended to expand the number of lens wearers, improve the patient wearing experience, and reduce the likelihood of patients dropping out of contact lenses, consumer research indicates that the number of contact lens wearers considering dropping out of contact lenses has been increasing (Figure 2) (Gallup, 2013). For patients considering dropping out, the most vulnerable time appears to be those with less than one year of lens wearing experience. The problems most often experienced relate to dis-comfort such as dryness and end of day discomfort. Problems with vision and handling are also common-ly experienced by today’s contact lens wearers.

Physiological characteristics of the wearer, physi-cal characteristics of the lens, and characteristics of the lens wearer’s visual demands and environment can contribute to the contact lens wearing experi-ence. Unraveling the major causes of discomfort is complex and difficult for researchers or academics to assess the reasons for comfort differences between different contact lenses since they cannot control for variables independently. For example, a lens material change would impact modulus, Dk/t, water content and coefficient of friction among other variables. Manufacturers on the other hand, have the ability to

Figure 2. Proportion of contact lens wearers considering discontinuation.

2009 2011 2012 2013

25%

20%

15%

10%

5%

11%

19% 20%18%

N E W P R O D U C T

40 as “uncomfortable; irritating or annoying,” 20 as “very uncomfortable; very irritating or annoying,” and 0 as “painful; difficult to wear lenses.”

Practitioners completed a slit lamp evaluation using a five-point scale. Slit lamp signs of epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, tarsal conjunctival abnor-malities, corneal neovascularization, and corneal in-filtrates were graded using an ordinal, text-based scale from which numeric grades in integer steps were as-signed, 0 (no finding), 1 (trace), 2 (mild), 3 (moder-ate) and 4 (severe). Patients with any graded infiltrate were not eligible for participation. For the remainder of graded signs, patients with findings greater than grade 1 were not eligible to participate. Practitioners also collected sphero-cylindrical refraction, slit lamp evaluation, lens centration and movement, and visual acuity (VA).

Patients were re-fitted to Bausch + Lomb Ultra contact lenses with MoistureSeal technology and Biotrue multi-purpose solution for 2 weeks. After the first seven days of product use, subjects responded to a Web-based subjective assessment evaluating com-fort, wettability, lens cleanliness, and other compo-

included in the study, patients needed to:• Spend at least 3 hours each workday using a

computer or electronic device (i.e. smartphones, tab-lets, eReaders)

• Subjects were myopic and required lens correc-tion from -0.25 D to -6.00 D in each eye

• Have worn their current lens brand for a mini-mum of one year

• Wear their current lenses for a minimum of 12 hours per day at least four days per week

• Be between the ages of 18 and 35 years• Have <= Grade 1 for corneal and conjunctival

assessments (see below) • Be absent of any corneal infiltrates

At the initial visit, patients rated symptoms associ-ated with their habitual brand of lenses using a 0-100 scale, with 0 denoting the least favorable rating and 100 denoting the most favorable score. To add con-text, descriptors were added to the rating scale for each category. As an example, the “end-of-day com-fort” category designated 100 as “excellent; cannot be felt,” 80 as “very comfortable; just felt occasionally,” 60 as “comfortable; noticeable but not irritating,”


Subject demographics and baseline eye characteristics.a

T A B L E 1

TOTAL

N = 341

ACUVUEOASYSN = 130

AIR OPTIX AQUA

N = 132

BIOFINITY

N = 79

Age

Mean 26.8 27.4 26.5 26.2

Min, max 18, 35 18, 35 18, 35 19, 35

Gender (%)b

Female 69.5 66.2 69.7 74.7

Male 30.5 33.8 30.3 25.3

Diagnostic refraction spherec,D

Mean/Median -3.36/-3.25 -3.37/-3.00 -3.23/-3.125 -3.54/-3.50

Min, max -6.75, -0.25 -6.50, -0.25 -6.75, -0.75 -6.50, -1.00

Diagnostic refraction cylinderc,D

Mean/Median -0.21/0.00 -0.21/ 0.00 -0.20/ 0.00 -0.23/-0.25

Min, max -0.75, 0.00 -0.75, 0.00 -0.75, 0.00 -0.75, 0.00

a Demographics and baseline eye characteristics are reported for eligible, dispensed subjects/eyes.b Percentages are based on the number of subjects with responses.c Diagnostic refraction sphere and cylinder are summarized at the eye level, while all other parameters are summarized at the subject level.

w w w. c l s p e c t r u m . c o m C O N TA C T L E N S S P E C T R U M / S P E C I A L E D I T O N 2 0 1 4 ■ 33

N E W P R O D U C T

nents of satisfaction with daily contact lens wear. Patient questionnaires were completed outside of the practitioner’s office to help ensure a higher level of objectivity.

After 14 days of wear, the patients rated symptoms associated with the Bausch + Lomb Ultra contact lenses. Practitioners once again collected sphero- cylindrical refraction, slit lamp evaluation, lens cen-tration and movement, and visual acuity (VA: made using logMAR acuity charts). In addition, practitio-ners provided their perspective on satisfaction overall and ease of fit through an on-line survey.

Statistical MethodsContinuous data was summarized using descriptive statistics: n, mean, standard deviation, minimum, and maximum. The differences in continuous end-points between study visits were assessed using paired t-tests. The differences in dichotomous categorical endpoints between study visits were assessed using McNemar’s tests. The p-values presented were two-sided, and evaluated using a 0.05 alpha level for each comparison. There were no interim analyses.

RESULTSStudy SubjectsThree hundred forty one silicone hydrogel patients were enrolled: 132 Acuvue Oasys (Vistakon) patients, 130 Air Optix Aqua (Alcon) wearers, and 79 Biofin-ity (CooperVision) wearers. Table 1 lists study subject demographics and baseline eye characteristics for the total population of dispensed patients and the three habitual lens cohorts. Average age for the study pop-ulation was 26.8 years with 69.5% being female and 30.5% male. The median refractive sphere and cyl-inder power was -3.25 D and 0.00 D, respectively. A comparison of habitual contact lens powers to study contact lens powers indicated that 92.7% of lenses were within +/- 0.25D. The most common branded contact lens care products used prior to entering the evaluation were Biotrue Multi-Purpose (22.6%) and Opti-Free PureMoist by Alcon (16.4%), Table 2.

The average daily wear time with habitual lenses was 13.9 hours. During a typical day, the study pop-ulation spent an average of 4.8 hours using a com-puter/laptop at the office and an average of 1.9 hours at home, Table 3. In addition, other digital devices (smartphone/tablet/e-Book) were used an average of 3.1 hours. Playing electronic games was reported to have the least amount of activity of those surveyed.

Table 4 presents the Snellen-equivalent, contact lens VA measures for the habitual lenses and dispensed

Bausch + Lomb Ultra lens at the dispensing visit and for the Bausch + Lomb Ultra lens at the 2-week follow-up visit. For these acuity measures completed in-office, the proportion of eyes with VA better than or equal to 20/20 were similar: 92.2% for the habitual

Habitual brands of contact lens care solutions

T A B L E 2

Brand % ofPatients

Alcon Opti-Free Express Multi-Purpose

4.7

Alcon Opti-Free RepleniSH Multi-Purpose

13.2

Alcon Opti-Free PureMoist 16.4

Alcon/CIBA Vision AQuify Multi-Purpose

1.8

Alcon/CIBA Vision ClearCare 10.6

AMO Complete Easy Rub Multi-Purpose

2.9

AMO RevitaLens Multi-Purpose Disinfecting Solution

0.6

Bausch + Lomb Biotrue Multi-Purpose solution

22.6

Bausch + Lomb renu fresh (ReNu MultiPlus) Multi-Purpose Solution

10.0

Bausch + Lomb renu sensitive (ReNu) Multi-Purpose Solution

1.8

Other Including Store Brand MPS (e.g. Walmart, Target, Publix)

15.4

Average hours spent doing each activity on a typical day

T A B L E 3

Activity Avg. Hours

Driving at night 1.1

Watching TV 2.0

Using a computer/laptop at Office 4.8

Using a computer/laptop at Home 1.9

Looking at a Smartphone/ Tablet/E-book

3.1

Reading books/magazines/ newspapers

1.4

Playing electronic games 0.4

lenses, 95.6% for the Bausch + Lomb Ultra lens at dispensing visit, and 93.3% for Bausch + Lomb Ultra lens at the 2-week visit.

Fit Characteristics Bausch + Lomb Ultra contact lenses were fully centered for 92.7% of eyes at the dispensing visit and for 95.1% of eyes at the follow-up visit, Table 5. There were no

N E W P R O D U C T

reports of corneal exposure at either visit. Ad-equate lens movement was reported for 95.7% of eyes at the dispensing visit and 96.6% of eyes at the follow-up visit. There were no re-ports of lens adherence at either visit.

Slit Lamp FindingsSlit lamp findings for each eye were graded for severity on a scale of 0 (no finding) to 4 (severe finding). Subjects were not en-rolled into the study if habitual lens slit lamp findings of grade 2 or higher were present. Results from the dispensing visit (habitual lens) and the follow-up visit (after wearing Bausch + Lomb Ultra) are summarized in Table 5 for the dispensed eyes. At the 2-week follow-up visit, only 2 eyes (0.3%) had find-ings greater than grade 2.

SymptomsThe in-office mean ratings of symptoms associated with the subject’s habital lenses and symp-toms associated with the Bausch + Lomb Ultra contact lenses are summarized in Table 6. The difference between the habitual baseline and Bausch + Lomb Ultra ratings at the 2-week visit was evaluated for statistical differences. All categories evaluated had ratings statistically more favorable for


Snellen equivalent Visual Acuity for Habitual lens and Bausch + Lomb Ultra lens

T A B L E 4

Snellen Equivalent

Habitual @ Dispensing

Visit

Bausch + Lomb Ultra @ Dispens-

ing Visit

Bausch + Lomb Ultra @ 2-week

Visit

20/9.5 0.3% 0.6% 0.9%20/12.5 6.2% 10.0% 10.2%20/16 41.1% 46.3% 46.8%20/20 44.6% 38.7% 35.4%20/25 6.7% 3.7% 5.8%20/32 1.0% 0.7% 0.5%20/40 0.1% 0.0% 0.3%

Worse than 20/40

0% 0% 0.1%*

Table 5. Graded slit lamp findings for dispensed eyes

T A B L E 5

Condition Dispensing Visit Follow-up Visit

Grade None Trace Mild Moderate Severe None Trace Mild Moderate Severe

Epithelial Edema

100 0.0 0.0 0.0 0.0 99.6 0.4 0.0 0.0 0.0

Epithelial Microcysts

99.4 0.6 0.0 0.0 0.0 99.7 0.3 0.0 0.0 0.0

Corneal Staining

78.5 21.5 0.0 0.0 0.0 75.3 22.5 2.1 0.1 0.0

Limbal Injection

91.7 8.3 0.0 0.0 0.0 94.6 4.9 0.4 0.1 0.0

Bulbar Injection

87.2 12.8 0.0 0.0 0.0 89.4 10.1 0.3 0.1 0.0

Tarsal Conjunctival Abnormali-

ties

75.6 24.4 0.0 0.0 0.0 74.9 25.0 0.1 0.0 0.0

Corneal Neovascular-

ization

98.0 2.0 0.0 0.0 0.0 98.1 1.9 0.0 0.0 0.0

* No reduction in best spectacle corrected visual acuity was observed for this subject’s eye as Snellen acuity was 20/20 at both baseline and exit.


the Bausch + Lomb Ultra contact lenses with the exception of Ease of Handling at Inser-tion which was not statistically significantly different. The largest differences favoring the Bausch + Lomb Ultra contact lenses were associated with comfort at end of day, (less) dryness, lens cleanliness upon removal, and vision in low light (p<0.05).

Patient Experiences Through the on-line survey, subjects rated performance attributes in various real-world situations. Overall, 87.4% rated the Bausch + Lomb Ultra contact lenses as either “excellent,” “very good,” or “good.” Accep-tance ratings for vision and comfort experi-ences associated with Bausch + Lomb Ultra were very high, Table 7. The proportions of subjects in agreement with the different per-formance statements associated with vision and comfort experiences were statistically significantly greater than 50%. Clear vision throughout the day (88.7%), when driving at night (88.0%), and when focusing for a long time at digital devices (87.4%) offered the highest agreement ratings. For comfort, the highest agreement ratings were for when driving at night (88.3%) and when focusing for a long time at digital devices (85.3%).

Preference results associated with comfort and vision are presented in Figure 3 and 4, respectively. In comparing Bausch + Lomb Ultra contact lens vision and comfort performance to the subject’s habitual lens, preference differences were statistically significant for the total cohort and for each of the individual sili-cone hydrogel lens brands (p<0.05). For all subjects with a preference, the Bausch + Lomb Ultra lens ex-perience was preferred for comfort: when working long hours on a computer (3.7:1), when focusing for a long time at digital devices (3.2:1), in dry environ-ments (3.0:1) and while driving at night (4.3:1). The Bausch + Lomb Ultra contact lens experience was preferred for clear vision: when working long hours on a computer (4.6:1), when focusing for a long time at digital devices (3.8:1), in dry environments (2.7:1) and while driving at night (5.3:1).

Overall, 78.8% of patients agreed that Bausch + Lomb Ultra contact lenses prevent eyes from feeling tired or fatigued even when you focus for a long time at digital devices. For all subjects with a preference, the Bausch + Lomb Ultra contact lens

experience was preferred for prevention of tired/fa-tigued eyes when focusing for a long time at digital devices (3.0:1).

Investigator PerspectivesFollowing the completion of each subject, the cumu-lative investigator satisfaction ratings demonstrated overall satisfaction with the outcomes for 98.2% of pa-tients. Based on the performance and fit characteristics, investigators indicated that the Bausch + Lomb Ultra contact lens was easy to fit for 98.9% of the patients evaluated (Figure 5).

DiscussionTo evaluate product performance, “real-world” non-randomized, prospective studies are used in broader patient populations and special patient subsets in general medicine (Beusterien et al, 2013; Boeru et al, 2013; Chaudhuri et al, 2014; Ge et al, 2011; Han et al,

N E W P R O D U C T

Mean rating for each symptom category using a scale of 0–100 (100 represents the most favorable rating) at baseline (Habitual) and after 2 weeks of wear.

T A B L E 6

Habitual Bausch + Lomb Ultra

Difference†

Comfort Upon Insertion

81.4 86.5 + 5.5*

Comfort at End of Day

62.8 75.4 +12.9*

Dryness 68.5 80.9 +12.8*

Redness 84.8 89.0 +4.5*

Vision 88.5 89.7 +1.5*

Vision in Low Light

80.5 87.4 +7.2*

Lens Cleanliness Upon Insertion

87.3 90.6 +3.4*

Lens Cleanliness Upon Removal

76.7 85.4 +8.8*

Ease of Handling/Insertion

87.0 86.8 -0.2

Ease of Handling/Removal

85.2 89.5 +4.3*

† Positive values indicate Bausch + Lomb Ultra lens rating is more favorable than Habitual lens rating

*Statistically significant p<0.05


2011) and optometry/ophthalmology (Blini et al, 2009; Crichton et al, 2010; Denis et al, 2010; Stonecipher et al, 2005).The pa-tients enrolled in this prospective, nonran-domized, open-label multi-center trial used various digital devices throughout their day that accumulated to over 9 hours (average).

The Bausch + Lomb Ultra contact lens with MoistureSeal technology is designed to meet the demands of today’s contact lens users. Long hours using digital display de-vices with infrequent and incomplete blinks can create wearing comfort and vision chal-lenges that previous generations of silicone hydrogel lenses may not have been designed to address. In this study sample of current silicone hydrogel wearing patients, the Bausch + Lomb Ultra contact lens improved the wearing experience associated with com-fort and vision. The in-office assessment of comfort symptoms indicated that the Bausch + Lomb Ultra contact lens pro-vided significant improvements in end-of-day comfort and a reduction in dryness.

N E W P R O D U C T

Extent of agreement by subjects with attributes of Vision and Comfort

T A B L E 7

Provide clear vision… % Agree

Throughout the day 88.7%

In dry environments 80.4%

When working for long hours at a computer 83.7%

When driving at night 88.0%

When focusing for a long time at digital devices 87.4%

Comfortable… % Agree

Throughout the day 82.2%

In dry environments 79.1%

When working for long hours at a computer 82.2%

When driving at night 88.3%

When focusing for a long time at digital devices 85.3%

Prevent eyes from feeling tired or fatigued even when you focus for a long time at digital devices.

78.8%

Figure 3. Percent of subject preference for comfort attributes

56.4

54.9

59.5

52.7

61

51.2

18.7

18.4

16.3

12.3

17.2

16.9

0 10 20 30 40 50 60 70

Throughout the day

In dry environments

When working for long hours at a computer

When driving at night

When focusing for a long time at digital devices

Prevent eyes from feeling tired or fatigued when focusing for a long time at digital devices

Bausch + Lomb Ultra Preferred Habitual Preferred


N E W P R O D U C T

that the Bausch + Lomb Ultra lens advancements will provide an improved lens wearing experience.

Throughout the evaluation, there were no de-vice related adverse events reported. Slit lamp find-ings revealed that 99.7% of eyes had minimal find-ings (no findings or trace or mild findings). Only two eyes associated with two patients had slit lamp findings greater than grade 2. With all subjects us-ing Biotrue multi-purpose solution, these low level of findings highlight the biocompatibility of both the Bausch + Lomb Ultra contact lens and Biotrue multi-purpose solution.

Investigators assessed centration and movement fitting characteristics at dispensing and after two weeks of wear. There were no reports of corneal exposure or lens adherence at either visit. Together with the fit, vision, and symptoms reports collected at all visits, practitioners expressed high levels of satis-faction overall (93.2%) and satisfaction with the ease of fit (98.9%).

Visual tasks connected with digital displays have been associated with changes in rate of blinks, the extent of blinks and the integrity of the tear film (Cardona et al, 2011; Chu et al, 2014; Himbaugh et al, 2009; Jansen et al, 2010; Patel et al, 1991; Por-tello et al, 2013). These alterations in blink patterns are also related to symptoms of dryness, discomfort,

When asked to assess lens comfort in various real world situations, the on-line survey substantiated the acceptability of the Bausch + Lomb Ultra contact lenses when worn in dry environments, when focus-ing for a long time at digital devices and when using a computer for a long time. The improvements in comfort were noted in patients re-fitted from Acuvue Oasys, Air Optix Aqua, and Biofinity contact lenses.

W i t h M o i s t u r e S e a l t e c h n o l o g y , t h e Bausch + Lomb Ultra contact lens is designed to re-tain moisture and provide a smooth optical surface to help prevent dehydration blur. The advanced aspheric optics design can also help reduce blurred vision, halos and glare in low light conditions. Although the “in-the-chair” Snellen visual acuity measurements were similar between the habitual and Bausch + Lomb Ultra lenses, the Bausch + Lomb Ultra contact lens performance results highlighted im-provements in the wearing experience associated with vision in real world situations that cannot be simulated in a practice environment. Both the in-office assessment of vision symptoms and the on-line survey substantiated improvements when wearing the Bausch + Lomb Ultra contact lenses compared to the habitual silicone hydrogel lenses. The preference associated with clear vision when working long hours on a computer and while driving at night indicate

Figure 4. Percent of subject preference for providing clear vision in real world conditions

52.5

52.1

59.2

53.7

51.8

14.4

19.6

12.9

10.1

13.8

0 10 20 30 40 50 60 70

Throughout the day

In dry environments

When working for long hours at a computer

When driving at night

When focusing for a long time at digital devices

Bausch + Lomb Ultra Preferred Habitual Preferred


N E W P R O D U C T

7. Portello JK, Rosenfield M, Chu CA. Blink rate, incom-plete blinks and computer vision syndrome. Optom Vis Sci. 2013;90(5):482-487.

8. Multi-Sponsor Surveys’ 2013 Gallup Study of the U.S. Con-tact Lens Market.

9. Jones L, Brennan NA, Gonzalez-Meijome J, et al. The TFOS International Workshop on Contact Lens Discomfort: report of the contact lens materials, design, and care subcommittee. Invest Ophthalmol Vis Sci. 2013;54(11):TFOS37-70.

10. Craig JP, Willcox MD, Argueso P, et al. The TFOS Interna-tional Workshop on Contact Lens Discomfort: report of the contact lens interactions with the tear film subcommittee. Invest Ophthalmol Vis Sci. 2013;54(11):TFOS123-156.

11. Efron N, Jones L, Bron AJ, et al. The TFOS International Workshop on Contact Lens Discomfort: report of the con-tact lens interactions with the ocular surface and adnexa sub-committee. Invest Ophthalmol Vis Sci. 2013;54(11):TFOS98-TFOS122.

12. Beusterien K, Tsay S, Gholizadeh S, Su Y. Real-world experi-ence with colorectal cancer chemotherapies: patient web forum analysis. Ecancermedicalscience. 2013;7:361.

13. Boeru G, Milanov I, De Robertis F, et al. ExtaviJect(R) 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study. Medical devices. 2013;6:175-184.

14. Chaudhuri N, Duck A, Frank R, Holme J, Leonard C. Real world experiences: pirfenidone is well tolerated in patients with idiopathic pulmonary fibrosis. Respiratory medicine. 2014;108(1):224-226.

15. Ge JB, Zhang F, Qian JY, Ge L, Liu XB, Zhou J. Six-month clinical outcomes of Firebird 2TM sirolimus-eluting stent implantation in real-world patients with coronary artery diseases. Chin Med J (Engl). 2011;124(6):831-835.

16. Han YL, Chen JY, Xu B, et al. Real world clinical perfor-mance of the zotarolimus eluting coronary stent system in Chinese patients: a prospective, multicenter registry study. Chin Med J (Engl). Oct 2011;124(20):3255-3259.

17. Blini M, Rossi GC, Trabucchi G, et al. Ocular hypotensive efficacy and safety of travoprost 0.004% in inadequately con-trolled primary open-angle glaucoma or ocular hypertension: short-term, multicenter, prospective study. Current medical research and opinion. 2009;25(1):57-63.

18. Crichton AC, Harasymowycz P, Hutnik CM, et al. Effective-ness of dorzolamide-timolol (COSOPT) in patients who were treatment naive for open-angle glaucoma or ocular hypertension: the COSOPT first-line study. J Ocul Pharma-col Ther. 2010;26(5):503-511.

19. Denis P, Baudouin C, Bron A, et al. First-line latanoprost therapy in ocular hypertension or open-angle glaucoma patients: a 3-month efficacy analysis stratified by initial intra-ocular pressure. BMC Ophthalmol. 2010;10:4.

20. Stonecipher K, Perry HD, Gross RH, Kerney DL. The impact of topical cyclosporine A emulsion 0.05% on the outcomes of patients with keratoconjunctivitis sicca. Current Medical Res Opin. Jul 2005;21(7):1057-1063.

Bausch + Lomb Ultra, MoistureSeal, renu, ReNu Multiplus, and Biotrue are trademarks of Bausch & Lomb Incorporated or its affiliates. All other product/brand names are trademarks of their respective owners.

US/ZUS/14/0124

blurred vision and visual fatigue. The extensive use of visual display activities by the patients in this study likely contributed to their reported symptoms of dry-ness, tired eyes, eye strain, blurriness or fluctuating vision when they entered the evaluation.

While previous silicone hydrogel contact lenses have made advancements in material chemistry and design, discomfort, blurry vision and cessation of lens wear continue to challenge contact lens wearers and eye care practitioners. With the MoistureSeal tech-nology and aspheric optics, the Bausch + Lomb Ultra contact lenses deliver improved comfort and vision wearing experience for patients. As vision demands associated with digital display devices increase, the Bausch + Lomb Ultra contact lens with MoistureSeal technology offers eye care practitioners a valuable tool for meeting patient’s needs. CLS

References1. Device Ownership Over Time, Pew Research Center’s

Internet & American Life Project. 2/15/2014. Available at: pewinternet.org/data-trend/mobile/device-ownership/

2. Cardona G, Garcia C, Seres C, Vilaseca M, Gispets J. Blink rate, blink amplitude, and tear film integrity during dynamic visual display terminal tasks. Curr Eye Res. 2011;36(3):190-197.

3. Chu CA, Rosenfield M, Portello JK. Blink patterns: reading from a computer screen versus hard copy. Optom Vis Sci. 2014;91(3):297-302.

4. Himebaugh NL, Begley CG, Bradley A, Wilkinson JA. Blink-ing and tear break-up during four visual tasks. Optom Vis Sci. 2009;86(2):E106-114.

5. Jansen ME, Begley CG, Himebaugh NH, Port NL. Effect of contact lens wear and a near task on tear film break-up. Optom Vis Sci. 2010;87(5):350-357.

6. Patel S, Henderson R, Bradley L, Galloway B, Hunter L. Ef-fect of visual display unit use on blink rate and tear stability. Optom Vis Sci. 1991;68(11):888-892.

Figure 5. Percent practitioner satisfaction Overall (A) and Ease of Fit (B)

93.2 98.9A B

Satisfied Not Satisfied

W e live in a screen-centric world where consum-ers spend more than 10 hours

a day using technology or electronic devices (Ipsos, 2012) and contact lens wearers are still looking for a lens that consistently provides comfort and clear vision throughout the day. With previous generations of contact lenses, patients have reported lower satisfaction and increased risk of drop-ping out of contact lens wear with in-creased hours of use of digital devices (Kadence, 2013).

One challenge associated with sus-tained visual tasks such as focusing on digital device screens is prevent-ing lens dehydration and maintain-ing the pre-lens tear film (PLTF) between successive blinks. Sustained visual tasks are also known to reduce blink rates (Bentivoglio et al, 1997; Cardona et al, 2011; Himebaugh et al, 2009; Portello et al, 2013). In general, the literature suggests that the resting average blink rate of 15 times per min-ute may be reduced to an average of 5 times per minute (Bentivoglio et al,

1997; Cardona et al, 2011; Himebaugh et al, 2009; Portello et al, 2013).

The quality and stability of the PLTF affects both the comfort and visual experience of the contact lens wearer. In one study, sixty percent of contact lens wearers who experienced symptoms of blurry or fluctuating vision felt that these symptoms had a negative impact on contact lens com-fort (Donnelly 2013). Ideally the PLTF would remain stable for the same peri-od of time as the pre-corneal tear film of the non-lens wearer. In reality how-ever, the lens alters the normal struc-ture and evaporation of the tear film and these factors have been associated with contact lens discomfort and can reduce visual quality (Guillon et al 2008; Korb, 1994).

PLTF stability is affected by both the magnitude and rate of water loss across the anterior surface of the lens (Nichols et al, 2006). Different contact lens materials behave differently in their ability to resist dehydration and maintain a consistent optical surface for great vision. Minimizing water loss across the surface of a lens may help to maintain a stable tear film, giving

By Kristen R . Hovinga, MS; Paul D. Ludington, MS; Mohinder Merchea, OD, PhD, MBA & Robert Steffen, OD, MS

The increased use of digital devices in today’s society has made it more important than ever to address lens dehydration.

Preventing Dehydration Blur

L E N S D E H Y D R A T I O N

Ms. Hovinga is a biomechani-cal design engineer and is part of the Lens Design group at Bausch + Lomb.

Dr. Merchea is former Executive Director, Head of Medical Affairs, Vision Care at Bausch + Lomb.

Mr. Ludington has more than 30 years of experience in optical design and engineer-ing, having worked at Bell Labs, Eastman Kodak and now at Bausch + Lomb. He is responsible for development of metrology for contact lenses.




from polymethylmethacrylate (PMMA) and mimics the optics and physical dimensions of an average hu-man eye with a 7.8mm radius and +0.18mm of spheri-cal aberration over a 6mm pupil. The USAF target (Figure 2) contains a series of horizontal and vertical 3-bar patches that represent specific spatial frequen-cies expressed as line pairs per millimeter. These spa-tial frequencies can be used to determine the contrast (the white letters against the black background) and resolution (the clearness or sharpness of the vertical and horizontal lines) thresholds for a contact lens when conformed to a model cornea. An image qual-ity metric which incorporates a cross-correlation al-gorithm for determining resolution and contrast was used on each of the USAF target images to generate a predicted logMAR visual acuity score for each lens. This easily understood metric provides a value which can be used to quantitatively assess changes in image quality for each lens over time.

Each lens was initially blotted to remove excess packaging solution from the lens surface and was conformed to the PMMA model cornea. Two drops of rewetting solution were used to simulate a fresh tear film after a blink. Multiple images of the USAF target were captured through each lens under am-bient room conditions (70ºF and 50% RH). Images were acquired every second for a total of 30 seconds and the predicted logMAR score for each lens at each time point were averaged for the 30 lenses measured for each brand. A Two Way – Repeated Measures ANOVA was conducted on the individual predict-ed logMAR scores using time and lens type as the main effects. Post-hoc analysis was performed using Tukey’s HSD test.

ResultsFigure 3 shows USAF target images representing the average logMAR score for each lens type captured at every ten-second time point. These images represent

a consistent optical surface, providing greater visual stability within typical blink rates at rest or during sustained visual tasks.

MethodsTo evaluate image quality during a simulated blink cycle, thirty (30) single vision contact lenses of Bausch + Lomb Ultra (samfilcon A), Acuvue Oasys (Vistakon – senofilcon A), Air Optix Aqua (CibaVision – lotrafilcon B) and Biofinity (CooperVision – com-filcon A) were measured using a novel optical bench technique. This in-vitro method predicts the logMAR retinal image quality based on the measured optical image resolution and contrast as the PLTF changes over time.

Figure 1 shows the optical layout of the imaging bench. The target was a chrome-on-glass US Air Force 1951 target. This target object was imaged through a Badal lens, the contact lens under test, a model cornea, and a 67D lens. The aerial image is then magnified by 10X onto a monochrome CCD camera.

The aspheric model cornea is diamond-turned

Figure 2. USAF 1951 target

Figure 1. Optical imaging bench layout



The Bausch + Lomb Ultra lens demonstrated bet-ter predicted logMAR scores at time-zero and at each additional time (10s, 20s, and 30s) compared to the three commercial lens products (p < 0.01 in all cases).

At time-zero, the Bausch + Lomb Ultra lens had at least a one-line improvement in predicted logMAR acuity compared to the other three sili-cone hydrogel lenses. Additionally, after 30s, the Bausch + Lomb Ultra lens had a 1.7 line average improvement over the lenses.

DiscussionWith the increased use of digital devices over the last several years, patients have reported lower sat-isfaction and increased risk of dropping out of con-tact lens wear as they spend more time using digital devices (Kadence 2013). Recommending a contact lens that improves patient experiences in these visual environments may improve patient satisfaction and retention in contact lens wear.

The ability of a contact lens material to resist de-hydration and maintain or stabilize the pre-lens tear film (PLTF) may help to provide a more consistent optical surface. Dehydration blur has been shown to be variable across different contact lens materials, and this may have a significant impact on visual quality and overall comfort that a patient experiences in con-tact lens wear in a variety of visual environments.

the image quality produced by each lens type over a 30 second time period. The Bausch + Lomb Ultra lens remained consistent with respect to the clarity of the images over the entire 30 second period. Other lens types showed reduced overall image contrast (image appears grayer) or reduced image clarity (smallest bar targets are not visible).

Figure 4 shows the mean predicted logMAR as a function of time for each lens, along with the ± one standard deviation for the sample of (30) lenses for each lens type. From this graph, it is evident that the Bausch + Lomb Ultra lens provides better image clarity and stability over time compared to the other products tested.

Figure 3. USAF images over a time frame simulating a range representing a blink cycle up to 30 seconds

Different contact lens materials behave differently in their ability to resist dehydration and maintain a consistent optical surface.

Biofinity

Bausch + Lomb Ultra

Acuvue Oasys

Air Optix Aqua


The better visual quality and predicted logMAR scores with Bausch + Lomb Ultra compared to the other leading silicone hydrogel lenses in the market is supported by aspheric optics and unique lens ma-terial properties that allow the lens material to help resist dehydration. Bausch + Lomb Ultra lenses start off clearer and remain clearer over the full 30 second test period in this in-vitro model designed to dem-onstrate the inherent ability of the lens material to resist dehydration. The 30-second time period is lon-ger than the average inter-blink period that the vast majority of patients would experience, even under reduced blink rate situations such as with the use of digital devices. CLS

References1. Ipsos OTX and Ipsos Gobal @dvisor. Socialogue: If You’re

Awake, Chances Are You Are Well-Connected. Available at: http://www.ipsos-na.com/news-polls/pressrelease.aspx?id=5725. Last accessed July 21, 2014.

2. Kadence International. Exploring Contact Lens Drop-off. May 2013.


Figure 4. Predicted logMAR as a function of time

Average Predicted logMAR (±1 Standard Deviation)

Elapsed Time (seconds)

Pred

icte

d lo

gMA

R

Better

0.7

0.6

0.5

0.4

0.3

0.2

0.1

0.0

-0.10 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32

samfilcon A

senofilcon A

lotrafilcon B

comfilcon B

3. Bentivoglio AR, Bressman SB, Cassetta E, Carretta D, Tonali P, Albanese A. Analysis of blink rate patterns in normal subjects. Movement disorders: official journal of the Movement Disorder Society. Nov 1997;12(6):1028-1034.

4. Cardona G, Garcia C, Seres C, Vilaseca M, Gispets J. Blink rate, blink amplitude, and tear film integrity during dynamic visual display terminal tasks. Curr Eye Res. Mar 2011;36(3):190-197.

5. Himebaugh NL, Begley CG, Bradley A, Wilkinson JA. Blinking and tear break-up during four visual tasks. Optom Vis Sci. Feb 2009;86(2):E106-114.

6. Portello JK, Rosenfield M, Chu CA. Blink rate, incomplete blinks and computer vision syndrome. Optom Vis Sci. May 2013;90(5):482-487.

7. Donnelly C, Nandakumar K, Raj S. Symptoms in CL wear —the unmet needs of the CL wearer. Optician. June 7, 2013:16-22.

8. Guillon M, Maissa C. Contact lens wear affects tear film evaporation. Eye Contact Lens. Nov 2008;34(6):326-330.

9. Korb DR. Tear film-contact lens interactions. Adv Exp Med Biol. 1994;350:403-410.

10. Nichols JJ, Sinnott LT. Tear film, contact lens, and patient- related factors associated with contact lens-related dry eye. Invest Ophthalmol Vis Sci. Apr 2006;47(4):1319-1328.

Bausch + Lomb Ultra is a trademark of Bausch & Lomb Incorporated or its affiliates. All other brand/product names are trademarks of their respective owners.

US/ZUS/14/0120


New Bausch + Lomb PeroxiClear™–the most advanced* peroxide solution.

Distributed by Bausch + Lomb, a Division of Valeant Pharmaceuticals, North America LLC, Bridgewater, N.J. PeroxiClear and PureVision are trademarks of Bausch & Lomb Incorporated or its affiliates.All other brand/product names are trademarks of their respective owners.©2014 Bausch & Lomb Incorporated. BLS07232 US/OCD/14/0002

Delivers Exceptional Disinfection P PPreservative Free P PProvides Superior All-Day Comfort1,2* PKeep Lenses Cleaner and Moister for Longer1-5* PLenses Are Ready to Wear in Only 4 Hours P

PeroxiClear™ Clear Care

REFERENCES: 1. Results from a 22-investigator, multi-site study of PeroxiClear™, with a total of 440 eligible subjects. Subjects were randomized to use either PeroxiClear™ or Clear Care for 3 months. Subjects completed performance surveys at 2-week, 1-month, 2-month, and 3-month visits. 2. Results from a 21-investigator, multi-site study of PeroxiClear™, with a total of 297 eligible subjects who were habitual Clear Care users. After 7 days of use, subjects completed an online survey. Consumers rated the performance of PeroxiClear™ across a range of attributes and compared the performance to their habitual Clear Care solution. 3. High-resolution/accurate-mass (HR/AM) mass spectrometry was used to detect and quantitate the relative amounts of surfactant retained on lenses from PeroxiClear™ and Clear Care solutions after 20 hours of wear. PureVision®2, ACUVUE OASYS, and AIR OPTIX AQUA lenses were soaked in solutions for 12 hours prior to patients wearing lenses for 20 hours. 4. Results of an in vitro study measuring deposits on ACUVUE OASYS lenses. Lenses were subjected to 14 cycles of deposition with a lipid and protein solution mimicking the human tear film followed by a cleaning regimen with either PeroxiClear™ or Clear Care 3% hydrogen peroxide systems. Each deposition/cleaning cycle was representative of one day of patient use. Cycled lenses (n=3) were analyzed for deposits using image analysis. After 14 cycles, lenses cleaned with PeroxiClear™ had only 8.0% surface coverage compared to 33.0% for lenses cleaned with Clear Care. 5. Results of an ex vivo study measuring deposits on worn contact lenses to compare the clinical performance of PeroxiClear™ and Clear Care solutions. Lenses were worn daily for 1 month (silicone hydrogel and Group IV hydrogel lenses) or 3 months (gas permeable lenses). A total of 374 lenses were randomly selected for image analysis. Lenses were scored for mean density of deposits and percent coverage of deposits.

Switch your patients to the most advanced* peroxide solution. Request your care kits today at Bausch.com/Peroxiclear.

Don’t just meetthe needs of your patients–exceed them.

*Compared to Clear Care


The concept of using hydrogen peroxide to disinfect contact lenses was originally intro-duced in the early 1970s

(Aquavella, 1971). Subsequently, a family of 3% hydrogen peroxide-based lens care solution products were devel-oped and commercialized. Currently, peroxide solutions remain a signifi-cant part of the US soft contact lens care solutions market and are used by approximately 20% of contact lens wearers (Nichols, 2014).

Hydrogen peroxide-based lens cleaning and disinfecting systems need to achieve adequate disinfection and also reduce the 3% hydrogen peroxide to residual levels that are safe for the human corneal surface. For any 3% hydrogen peroxide system, the residual hydrogen peroxide concentration fol-lowing neutralization must result in minimal to no change in the cellular structure or integrity of the corneal epithelium and also must not elicit a physiological response that may lead to patient discomfort. Although the safety

threshold levels reported in the litera-ture remain controversial, these values typically range from 100 – 250 ppm (Chalmers and McNally 1988, Paugh, Brennan et al. 1988, Konynenbelt, Mlnarik et al. 2011).

Two different types of peroxide lens care systems have been introduced to clean and disinfect soft contact lenses and reduce the 3% hydrogen peroxide to a safe residual level. They are clas-sified as either one-step or two-step contact lens disinfecting systems based on the method used to neutralize the hydrogen peroxide.

Two-step systems require a separate neutralizing agent, typically a tablet, which is added during the disinfec-tion step and releases an enzyme such as catalase. Hydrogen peroxide levels remain at 3% until the catalase is re-leased from the coated tablet and then rapidly decrease to safe residual levels. Two-step hydrogen peroxide systems are generally considered very effective at disinfection based on the initial high peroxide concentration. However, it has been shown that the catalase tab-

B y K i m b e r l y A . M i l l a r d , M S ; D a n i e l H o o k , P h D ; A n d r e w H o t e l i n g , P h D & K a t a r z y n a W y g l a d a c z , P h D

Development of a cleaning and disinfecting solution with a platinum-modulating compound.

A One-Step Hydrogen Peroxide-based Contact Lens Solution

P E R O X I D E S O L U T I O N S

Dr. Wygladacz is a Senior Research Scientist in Vision Care R&D at Bausch + Lomb, a division of Valeant.

Dr. Hoteling is a Principal Scientist with Bausch + Lomb, a division of Valeant.

Dr. Hook is a Senior Principal Scientist at Valeant and Group Leader of the Structur-al and Surface Science Group within Bausch + Lomb.

Ms. Millard is a senior re-search scientist in Vision Care at Bausch + Lomb, a division of Valeant Pharmaceuticals. She has more than 18 years of experience in the medical device and pharmaceutical industries.


oxide solution may effectively control the neutraliza-tion process (Millard et al, 2013). Depending on the compound properties, this interaction may be revers-ible or irreversible (Millard et al, 2013). PMCs have the ability to slow peroxide neutralization during the initial disinfection time (i.e., the first 30-60 minutes) leaving a solution virtually free of viable organisms while at the same time rendering residual peroxide concentration levels that are non-irritating to ocular tissues in only four hours (Millard et al, 2013).

The addition of a PMC to the peroxide disinfecting solution modifies the neutralization profile of hydro-gen peroxide, effectively increasing the amount of to-tal peroxide exposure available to kill microorganisms. The goal of incorporating a PMC is to increase the total peroxide exposure while reducing the actual time of disinfection, and thus allow for safe levels of residual peroxide to be achieved in a shorter overall regimen.

Mechanism of ActionTo further understand the mechanism of action of PMCs and how they could be applied to develop a next generation hydrogen-peroxide system, the in-teraction between peroxide neutralizing discs and PMCs has been evaluated (Millard et al, ARVO, 2014). Although many PMCs were screened (Millard et al, GSLS, 2014), carbamide and thiourea were selected for further study. These compounds are structural analogues that differ only by one atom and yet their neutralization profiles are distinctly different. Equi-molar amounts of carbamide and thiourea were added to 3% hydrogen peroxide solution and the neutraliza-tion profiles were measured. In addition, a solution of 3% hydrogen peroxide without the addition of a PMC was used as a control. Figure 2 shows that the addition of the PMCs significantly changed the neutralization profile of the 3% peroxide solutions based on titration measurements of hydrogen peroxide concentration. Compared to the 3% peroxide control, carbamide de-layed or initially slowed the neutralization while the addition of an equimolar amount of thiourea result-ed in virtually no peroxide neutralization even after

lets may dissolve at different rates, resulting in variable peroxide neu-tralization rates (Ngo et al, 2009).

The most popular of today’s hydrogen peroxide-based contact lens disinfecting systems con-tain 3% hydrogen peroxide in a buffered solution and use only one simple step to neutralize the hydrogen peroxide. These one-step disinfecting systems catalyze neutral-ization of hydrogen peroxide via a process driven by a platinum catalyst attached to the lens holder.

Although one-step systems are very simple to use, most of the hydrogen peroxide is neutralized relatively rapidly over the first 30-60 minutes (Nicolson et al, 1993; Millard, Xia et al, 2013). In effect, the amount of hydrogen peroxide available to disinfect the lens decreases quickly and a longer total disinfection/neutralization time is needed to achieve the desired anti-microbial efficacy. The advantage of the two-step systems is that the neutralization of hydrogen perox-ide may be delayed allowing enhanced anti-microbial efficacy compared to one-step systems.

Typically, first generation one-step peroxide sys-tems require a 6 hour regimen time in order to achieve sufficiently low residual peroxide levels and adequate disinfection efficacy. However, performance of a one-step disinfecting system could be significantly im-proved by controlling the rate of hydrogen peroxide neutralization. In other words, delaying the neutraliza-tion of hydrogen peroxide should allow for higher to-tal peroxide exposure, improving efficacy , and reduc-ing microbial contamination (Penley et al, 1985). This transient delay would ideally be followed by an accel-erated neutralization phase resulting in a shorter total regimen time offering both efficacy and convenience to the user. A challenge for contact lens care formula-tors has been to develop a one-step system with a 3% hydrogen peroxide solution with controlled neutral-ization in the initial phase of disinfection. Controlled neutralization would enable excellent disinfection ef-ficacy and result in residual peroxide levels that would not cause ocular discomfort or physiological damage. Ideally, a one-step peroxide solution with controlled neutralization would also offer an additional advantage of a shorter overall regimen time (Millard et al, 2013).

Platinum Modulating CompoundsPlatinum modulating compounds (PMCs) are organic molecules that typically consist of nitrogen, carbon, and oxygen. Two examples are carbamide and thiourea (Figure 1), which when added to a 3% hydrogen per-

Figure 1. Chemical structures of the platinum modulating compounds carbamide (A) and thiourea (B).


To better understand the mechanism of action, the interaction of carbamide and thiourea test solutions with platinum discs was studied using two comple-mentary surface sensitive analytical techniques; time of flight secondary ion mass spectroscopy (ToF-SIMS) and X-ray photoelectron spectroscopy (XPS). While ToF-SIMS analysis provides qualitative information and determines the structural constituents of a mol-ecule, XPS was used to identify the elements present on the surface and quantitate them.

Platinum discs were incubated overnight with 10 mL of 2% carbamide or thiourea in 20 mM phos-phate buffer saline (PBS) solutions. The discs were rinsed with purified water then carefully cut and mounted for ToF-SIMS and XPS characterization.

The ToF-SIMS results definitively showed that both carbamide and thiourea were present on the plat-inum disc surface. The images in Figure 3 show the relatively uniform distributions of carbamide or thio-urea observed on the platinum surface.

XPS analysis was used to quantitate the concen-tration of the detected elements distributed over the surface of the platinum discs. Concentration of nitro-gen, the element common for both PMCs, was used to compare affinity of carbamide and thiourea to plati-num substrates. The data is shown in Table 2. The cal-culated atomic concentration of nitrogen for the discs exposed to thiourea buffered solution (N1s = 11.6 ± 2.1) was two times higher than the value calculated for the discs soaked in carbamide buffered solution (N1s = 5.8 ± 1.8). These results indicated stronger attrac-tion of thiourea to the platinum discs and correlated well with the differences in neutralization profiles dis-played in Figure 2.

Additionally, the XPS results demonstrated a de-crease in platinum concentration (Pt4f7) for the discs incubated in any PMC solution (Pt4f7 = 19.6 ± 4.7 (carbamide), Pt4f7 = 14.2 ± 1.8 (thiourea), respective-ly) compared to the fresh platinum substrates (Pt4f7 = 25.3 ± 8.0). This indicates that the discs soaked either with carbamide or thiourea were covered with PMC compounds and therefore lower platinum concentra-tions were detected by XPS.

Coverage of the platinum discs with PMC compo-nents was of interest in these studies. Spatial distribu-tion of the elements such as nitrogen and sulfur over the platinum cut discs was examined by XPS mapping (Figure 4). Concentration of the element of inter-est was displayed using a color-coded intensity scale. While black indicated no particular element was de-tected, the areas of intensity that appeared yellow-to-white corresponded to its highest concentration

4 hours. These results clearly indicate the significant impact on the peroxide neutralization profile when a PMC is added to a 3% hydrogen peroxide solution that is neutralized with a platinum coated disc. Addi-tionally, careful selection and an optimized concentra-tion of a given PMC allows the neutralization profile to be controlled.

The neutralization profiles can be used to calculate the total area under curve (AUC) to derive total perox-ide exposure, expressed as ppm·hours. The calculated total peroxide exposure values for 3% peroxide without a PMC (control), 3% peroxide with carbamide, and 3% peroxide with thirourea are shown in Table 1. These values represent the total peroxide exposure available to kill microorganisms during the targeted 4-hour neu-tralization time. At first glance, the control and carb-amide neutralization profiles (Figure 2) look similar; however, the total peroxide exposure value of 3% per-oxide with carbamide is approximately twice that of the control solution without a PMC.


Figure 2. Neutralization profiles of 3% hydrogen peroxide solution with addition of equimolar concentrations of platinum modulating compounds (PMCs) and a neutraliza-tion profile recorded for a 3% peroxide control solution.

Total hydrogen peroxide exposure (area under curve) of test (3% peroxide with carbamide, and 3% peroxide with thiourea) and control (3% per-oxide without a PMC) solutions.

T A B L E 1

PMC Compound AUC (ppm-hrs)

Control 7730

Carbamide 16114

Thiourea 90334

w w w. c l s p e c t r u m . c o m C O N TA C T L E N S S P E C T R U M / S P E C I A L E D I T O N 2 0 1 4 ■ 47


on the surface. XPS mapping performed for the discs incubated in carbamide and thiourea showed uniform distribution of PMCs over the platinum disc surfaces and no evidence of PMC component aggregation was detected.

Leveraging PMCs in Novel Lens Care Solution DevelopmentThe PMC interaction with the platinum sites on the neutralizing disc is new technology that allows for the controlled neutraliza-tion of a 3% peroxide solu-tion. PMCs help one-step peroxide systems mimic the slow initial neutralization of a two-step peroxide system without the inconvenience

of a second step. This PMC technology was incor-porated into the development of a one-step peroxide system — PeroxiClear cleaning and disinfection solu-tion — which utilizes a combination of three differ-ent moisturizing agents to attract, spread and retain moisture on the surface of the lens. Carbamide, one of these three ingredients, serves a dual purpose as both a natural moisturizing factor to help prevent dehydra-tion, and as a platinum modulating compound.

The addition of a PMC in PeroxiClear solution alters the typical peroxide neutralization profile com-pared to other peroxide contact lens cleaning and disinfecting solutions. For example, in a comparison of total peroxide exposure for PeroxiClear and Clear Care (Alcon), the mean total AUC measurements were calculated at 4 hours for PeroxiClear and 6 hours for Clear Care. Both product systems were tested four times and peroxide concentrations were plotted to generate neutralization curves. As a result of the slower initial neutralization produced by the PMC, PeroxiClear had a statistically significantly higher total peroxide exposure in 4 hours compared to Clear Care after 6 hours (based on manufacturer recommended disinfection times) (p<0.0001) (Figure 5).

In addition to total peroxide exposure, the mean residual hydrogen peroxide concentration for PeroxiClear 3% hydrogen peroxide system was also tested. Ten lens cases were cycled one time with 10 mL aliquots of the solution and soaked for the rec-ommended regimen time of 4 hours. Residual peroxide

Figure 3. ToF-SIMS results for carbamide and thiourea

Figure 4. Spatial distribution of nitrogen (N1s) and sulfur (S2p) over exemplary plati-num (Pt4f7) cut discs exposed to carbamide and thiourea buffered solutions.

concentrations were measured using redox titration with a Mettler Toledo T50 Auto-Titrator. The mean residual peroxide level for PeroxiClear solution after 4 hours was 64.8 ± 12.3 ppm, well below thresholds for ocular detection or cellular changes (Chalmers et al, 1988; Paugh et al, 1988; Konynenbelt et al, 2011).

Physico-Chemical ChangesWhen XPS elemental composition data was used to quantitate the relative amounts of carbamide adsorbed to the platinum sites during the neutralization process for PeroxiClear at 0, 5, 15, 30 and 60 minutes, an in-crease in the carbamide detected on the platinum sites on the coated disc surface was evident from 0-30 min-utes. At 60 minutes, the atomic coverage (%) decreased.

The loss in affinity of carbamide for the platinum surface after 60 minutes may be attributed to the si-multaneous physico-chemical changes in tempera-


ture, pH and osmolality within the case during the first 60 minutes of neutralization. This is evidenced by the results of timed evaluations of temperature, pH and osmolality during the neutralization process. Within the first 0-60 minutes of neutralization, the temperature of the carbamide test solution increases, the pH increases and the osmolality decreases rapidly.

ConclusionCombination of a suitable PMC such as carb-amide with 3% hydrogen peroxide was shown to be a breakthrough approach that may im-prove the performance of peroxide-based lens care solutions. Application of this technology in PeroxiClear cleaning and disinfecting solution allowed for a higher total hydrogen peroxide exposure, in only 4 hours, and residual peroxide levels that are non- irritating to ocular tissues. CLS

References1. Aquavella JV, GK Jackson, Guy LF. Bionite hydrophilic

contact lenses used as cosmetic devices. Am J Ophthalmol 1971;72(3):527-531.

2. Nichols JJ. Annual Report: Contact Lenses 2013. Contact Lens Spectrum; January 2014.

3. Chalmers RL, McNally JJ. Ocular detection threshold for hy-drogen peroxide: Drops vs. Lenses. ICLC 1988;15(11):351-357.

4. Paugh JR, Brennan NA, Efron N. Ocular response to hydrogen peroxide. Am J Optom Physiol Opt 1988;65(2):91-98.

5. Konynenbelt, B. J., D. S. Mlnarik and J. L. Ubels. Effects of peroxide-based contact lens-disinfecting systems on human corneal epithelial cells in vitro. Eye Contact Lens 2001;37(5): 286-297.

6. Ngo W, Heynen M, Joyce E, Jones L. Impact of protein and lipid on neutralization times of hydrogen peroxide care regi-mens. Eye Contact Lens 2009;35(6):282-286.

7. Nicolson P, Seamons KR, Tsao F, Alvord LA, McCraw EC, Inventors. Peroxide Disinfection Method. US patent 5,306,352; 1993.

8. Millard KA, Xia E, Groemminger S, Kilbury J. Peroxide Lens Care Solution. U.S. Patent Application 13/835237, filed March 15, 2013. Pub. No.: US 2013/0209313.

9. Penley CA, Llabres C, Wilson LA, Ahearn DG. Efficacy of hydrogen peroxide disinfection systems for soft contact lenses contaminated with fungi. CLAO J 1985;11(1):65-68.

10. Millard KA, Groemminger S, Hoteling A, Hook D, Wygla-dacz KA. Surface Characterization of the Interaction Between Peroxide Neutralizing Disks and Platinum Modulating Com-pounds. ARVO 2014. Orlando, Florida.

11. Millard KA, Groemminger S, Xia E, Kilbury J. Evaluation of Platinum Modulating Compounds to Delay the Neutraliza-tion of Hydrogen Peroxide in One-Step Disinfecting Systems. Global Specialty Lens Symposium 2014. Las Vegas.

PeroxiClear is a trademark of Bausch & Lomb Incorporated or its af-filiates. All other brand/product names are trademarks of their respective owners.

US/OCD/14/0054


Figure 5. Total peroxide exposure during the manufacturers’ recommended disinfecting time for PeroxiClear (4 hours) and Clear Care (6 hours).

Atomic Concentration (%) – average values – calcu-lated for nitrogen (N1s) and sulfur (S2p) detected by XPS on the surface of the platinum (Pt4f7) discs exposed to carbamide and thiourea buffered solu-tions. The data were calculated for n = 20.

T A B L E 2

PMC Compound

Nitrogen(N1s)

Sulfur(S2p)

Platinum(Pt4f7)

Control* N/A N/A 25.3 ± 8.0

Carbamide 5.8 ± 1.8 N/A 19.6 ± 4.7

Thiourea 11.6 ± 2.1 4.7 ± 0.7 14.2 ± 1.8

Silicone hydrogels were first introduced in the late 1990s. The goal was a healthier contact lens when compared to the low Dk

hydrogel materials available at the time to improve oxygen transmission to the eye. While we’ve seen a de-crease in conditions such as corneal edema, microcysts and neovasculariza-tion, and a reduction in limbal redness (Fonn et al, 2006), the most common complaint I hear from patients is about contact lens-associated dryness. This isn’t news to any of us. With research indicating current contact lens drop-out of 10 to 20% annually (Rumpakis, 2010), we have yet to address the issue of dryness. The digital age of constant computer and smart phone use doesn’t help the matter. With a 65% decrease in blink rate with sustained visual tasks (Patel et al, 1991), contact lens patients may experience daily grittiness and ir-ritation to a greater extent than we are possibly aware.

In my practice, I like to offer my patients a healthy contact lens with exceptional comfort and optics in one package. Over the past few years, we’ve

been fortunate to have new materials introduced for daily disposable use, monthly use, and even new cosmetic lenses. How do my staff and I engage in a discussion about new contact lens technology in a presumed-satisfied contact lens wearer who walks in after 18 months for a prescription renewal?

Asking the Right QuestionsDoes this sound familiar? You enter the room to see your next contact lens pa-tient. You drop into the chair, smile at the patient, and welcome him to your office. You thank him for choosing to come to you for his eye care. One of the first questions you ask is “So how are your contact lenses?” The patient reports they are “fine.” That may seem sufficient at first thought. If patients truly had problems, they would tell us, right? Studies indicate that as many as 2 out of 3 patients don’t discuss contact lens issues they may be having with their eye care practitioner (Kadence survey, 2012). Why is this? Are they afraid we’ll tell them they can no lon-ger wear contact lenses if they say they experience contact lens discomfort, or their eyes feel dry or they struggle

B y M a t t h e w W a r d , O D

Even when patients say, “I’m happy with the lens I have.”

Growing My Practice With a Novel Contact Lens Technology

P A T I E N T R E L A T I O N S

Dr. Ward is an optometrist with Eye Care of Iowa, a five-location private practice in central Iowa. His interests include dry eye and ocular nutrition. He has received honoraria in the past year for speaking and writing from B+L and TearScience. You can reach him at [email protected].




patient work-up) can better elicit any issues the pa-tient may be having, that our routine questions may not be able to uncover. This gives us an incredible op-portunity to introduce new technology and improve patient satisfaction. The patient will appreciate our practice more and also be more likely to remain in contact lens wear. Taking the time to ask open-ended questions may lead to a more successful contact lens patient, which in turn could increase the patient’s loy-alty to you and your practice.

Another habit I’ve tried to change in my practice is related to asking patients how many boxes of contact lenses they would like to purchase at the end of a visit. This habit is the reason why so many of our patients typically used to order only one or two boxes. We know this leads to the risk of non-compliance (using the contact lenses longer than recommended) or or-dering contact lenses online or from another provider. In my practice, I prefer to recommend monthly re-placement lenses and my newly established habit is to assume that a patient wants an annual supply of lens-es from our office. We no longer ask patients “How many?” Instead we say, “The doctor has approved an annual supply.” This, in addition to competitive pric-ing and rebate programs, helps to keep patient contact lens purchases in our practice.

In my practice, I’ve implemented a change in many of the habits we’ve developed in how my staff and I interact with contact lens patients and I can see the return on the investment in a better relationship with my patient and more patients choosing to get their annual supply of contact lenses from my office versus shopping around.

The Next Best ThingI pride myself on offering the newest and greatest in contact lens technology, particularly for patients who may be experiencing dissatisfaction associated with dryness symptoms or discomfort with their current contact lenses. But it’s up to us, the eye care profession-als, to uncover the underlying dissatisfaction before it leads to a patient discontinuing contact lens wear.

As I become more familiar with a new lens technol-ogy, I typically start to recommend this new technol-ogy to all patients, even those who don’t have outright complaints of discomfort. Imagine that. Taking a pa-tient with zero complaints, 20/20 vision and a white healthy eye, and offering him something new. Waste of time? No way. Although a patient may not have an overt complaint, he may not recognize that there could be a higher benchmark for comfort or vision. I’ll ask my patient, “Would you like to have more

with their vision through the day? And what impact does this unrecognized or hidden dissatisfaction have on the risk for contact lens dropout?

For example, asking a patient about their end-of-day comfort can frequently result in a patient re-sponse of “they’re fine.” We could leave it at that and let muscle memory take over. We could reach for the same box of lenses the patient has been wearing and send him off with a prescription or usually something less than an annual contact lens supply, with the hope that he’ll return for an eye exam in 12 to 18 months. But is this patient truly happy and satisfied with con-tact lens wear? Have we done our due diligence in assessing patient satisfaction?

Fitting contact lenses is a routine/repetitive part of practice for most of us, a routine that we don’t even think about most of the time. It’s become a habit, and habits (good or bad) are very hard to change. In fact, fitting contact lenses is such a strong habit that many of us can do it without even ‘actively’ thinking about it (like when you end up in your drive way and can’t quite remember all the things that you encounter on the way home). Once habits are established, they actu-ally involve less thinking or engagement on our part.

All of us have habits, including many good ones. The key is to recognize a habit loop and what the cues are which trigger them (Duhigg, 2014) in order to under-stand how we can change them for the betterment of our patient’s contact lens-wearing experience and our practice profitability. One of the simplest habit chang-es we’ve employed where I practice is to ask more de-tailed questions about each patient’s contact lens expe-rience. For example, “Do your lenses feel just as good in the evening as they do in the morning? Do you find your vision fluctuating throughout the day? Do you find yourself blinking or rubbing at your eyes to try to clear up your vision?” Taking an extra 30 seconds to ask these questions (or have your staff ask during a

Taking the time to ask open-ended questions may lead to a more successful contact lens patient, which in turn could increase the patient’s loyalty to you and your practice.


comfortable, consistent vision throughout the day? Would you like a contact lens that dehydrates more slowly, such as when you work on the computer?

SummaryNovel contact lens technology now provides patients with an exceptionally healthy contact lens, providing comfortable and great vision throughout a full day of wear. More and more patients are returning to my of-fice stating that while they thought their old lenses were “comfortable,” this new lens brings “comfort” to a whole new level. Where some of my patients may have come to think that contact lens wear was not go-

Although a patient may not have an overt complaint, he may not recognize that there could be a higher benchmark for comfort or vision.

ing to be a long-term option for them because of on-going discomfort or vision issues, we’re finding great success in fitting new contact lens options coming on the market. CLS

References1. Fonn D, Dumbleton K, Jailber I, Sivak A. Benefits of Sili-

con Hydrogel Lenses. Contact Lens Spectrum. http://www.clspectrum.com/articleviewer.aspx?articleid=12955. Published February 1, 2006.

2. Rumpakis J. New Data on Contact Lens Dropouts: An Interna-tional Perspective. Rev Optometry. http://www.revoptom.com/content/d/contact_lenses_and_solutions/c/18929/. Published January 15, 2010.

3. Patel S, Henderson R, Bradley L, Galloway B, Hunter L. Effect of visual display unit use on blink rate and tear stability. Optom Vis Sci. 1991 Nov;68(11):888-92.

4. Exploring Comfort and Vision Survey - Kadence International, 2012. Phase 1: A total of 568 contact lens wearers (136 daily dis-posable, 432 planned replacement) completed an online survey regarding comfort and vision symptoms associated with contact lens wear. Phase 2: A random subset of 287 contact lens wearers (78 daily disposable, 209 planned replacement) were then asked to track vision and comfort symptoms and complete a second online survey

5. Duhigg C. The Power of Habit: Random House Trade Paper-backs; 2014.

US/ZUS/14/0125

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Contact Lens Practice PearlsB Y J A S O N R . M I L L E R , O D , M B A , F A A O

Dr. Miller is in a partnership private practice in Powell, Ohio, and is an adjunct faculty member for The Ohio State University College of Op-tometry. He has received honoraria for writing, speaking, acting in an advisory capacity, or research from Alcon, Allergan, CooperVision, and Visioneering Technologies. You can reach him at [email protected].

IThe Contact Lens Conversation

n the changing face of health care, contact lenses are vitally important to most eyecare prac-tices. Advanced contact lens materials, designs and solution systems have improved our ability to

provide a comfortable contact lens-wearing experience, but we need to better utilize new tech-nology and work to understand our patients’ concerns and com-fort issues so we can keep them comfortable in their lenses. All of this starts with asking the right questions.

How do you talk to your pa-tients about the comfort of their contact lenses?

• Is it a quick, “how are you doing with your contact lenses? Good? Then I’ll renew the con-tact lens Rx with the same lenses.”

• A little more involved, “Do your lenses feel comfortable?”

• Or is it a full press, “Do your contact lenses feel as comfortable at the end of the day as at the beginning? Are they equally com-fortable at the beginning of the wear cycle compared to the end of the wear cycle? When using a computer, do you experience any intermittent blur? Do you work outdoors and if so, do you use eye drops during the day to help with comfort?”

In addition, how are comfort questions asked?

• Via a paper questionnaire?• By staff during the history?• Or do you ask patients?

Address the IssueContact lens comfort needs to be

questions.• Rate your comfort from 1 to

10 upon contact lens insertion• Rate your comfort from 1 to

10 at the end of the day• How many hours do you

wear your lenses per day and would you like to be able to wear them longer?

• Rate your vision while at the computer

Then, you follow-up with more probing questions from behind the slit lamp;

For example, you could say “Comfort is a priority in my office. Is there anything you would like to see improved with your current lenses or the wear-ing schedule?

If there are concerns, address them and offer alternatives. If comfort truly is a focus within your contact lens practice, a pro-tocol for these questions should be developed and used at every encounter. We all want our pa-tients to feel as comfortable as possible in their contact lenses. When we continue to offer the newest innovations in contact lens materials, modalities and care products, we can be confident we’re giving our patients their highest chance for success. CLS


at the forefront, because the sta-tistics are staggering — a single dropout could cost $275 in lost annual revenue, and this doesn’t include the future value of treat-ing the patient and potential re-ferrals (Rumpakis 2010). As a vast majority of contact lens dropouts are due to discomfort (Nichols et al, 2005; Guillon and Maissa, 2005), exploring ways to improve comfort must be at the heart of your efforts.

Look for ItA careful corneal evaluation can identify potential complications along with specific treatment regimens for contact lens candi-dates. A detailed corneal assess-ment before, during and after the initiation of contact lens wear — is essential to preventing contact lens dropouts.

This is a great time to ask about comfort. Ask when you’re behind the slit lamp and you may be surprised what you hear.

Silent DropoutsDon’t assume your patients are wearing their contact lenses com-fortably; they may have silently dropped out of contact lens wear without your knowledge.

To prevent or identify these silent dropouts, consider asking or having your staff ask these core


The Business of Contact LensesB Y G A R Y G E R B E R , O D

Dr. Gerber is the president of the Power Prac-tice, a company offering proven and compre-hensive practice and profit building systems. You can reach him at www.PowerPractice.com and follow him on Twitter @PowerYourDream.

MAssessing the Value of Adding New Technology

aking a decision about whether to bring a new prod-uct or technology into your practice isn’t always as straightforward as it may seem. On the clinical side, the decision is relatively easy, especially for

new products. For example, if a new contact lens is clinically superior, and you’re committed to providing the best care to your patients, the decision is already made. This assumes you have a practice mission that includes this sentiment about patient care. This goes to the difference between simply saying you’ll do something vs. actually doing it. In this case, if your practice is about providing the best — provide it.

Of course, “new” doesn’t always equal “best.” But since it often does, it behooves you to at least try new products so you can decide for yourself. Waiting until others have tried something new isn’t necessarily bad, but there can be significant marketing benefits to being a “first mover.”

Because of the cost, it’s often more challenging to introduce new technology (versus products) into your practice. Fitting a new contact lens may involve little or no investment, but that’s often not the case with technology.

Usage and ROIThe biggest wildcard for most practices is anticipated usage. If you lease something, it’s easy to calculate how many times per

you’ll need to use the widget 20 times per month and sell products to all 20 patients.

Gauging Patient InterestTo use this model, you have to know what you’ll charge and have a good sense of your patients’ willingness to move forward with recommended tests or treatments. That part is as easy as asking, “Mrs. Dry Eye, we’re considering adding some new technology to the office. It helps to better diag-nose your dry eyes and it works by . . . The charge for the test is $XX and it is (or isn’t) covered by your insurance. If we were to bring it into the office, how likely would you be to have the test done?”

Patients who express an inter-est should be kept on a list and notified as soon as you’re trained on the new equipment. Depend-ing what you buy, what it costs and your patients’ interest, you might consider paying cash versus financing if enough patients are on your list.

Assess Before You InvestIf you assess anticipated usage and ROI, along with volume and patient interest, you should have a pretty good idea if it makes sense to move forward with a particular piece of new technology. CLS

month you’ll need to use the device to cover the cost of the lease. Of course, using new tech-nology to break even is a poor business strategy so it’s better to build in the desired amount of profit you’d like each month and use that to evaluate ROI and guide your decision. Some of the profit may come directly from the device and some of it may come indirectly from it. For example, if it’s used to help diagnose dry eye, you may find added revenue in the extra office visits and products you sell for dry eye.

VolumeAnticipated volume predictions are easy. Just make a list of how many times in a month you would have used the new technology, if you had it. Then, you can deter-mine if the new equipment is a fiscally sound purchase. Remem-ber to consider any incremental profit you’d make from additional visits or sales of products.

So for example, if the widget payment is $1,000 per month and you plan on charging (and collecting) $50 from each test you run and selling $50 worth of related products, and you want to make $1,000 a month profit,


Pediatric and Teen CL CareB Y J E F F R E Y J . W A L L I N E , O D , P H D , F A A O

AMyopia Control Consent Form

burgeoning area of contact lens innovation is myopia control. While there are several brands believed to slow myopic growth of the eye, none are approved by the FDA for the purpose of

myopia control. Although contact lenses currently used off label for myopia control are approved for wear without age restriction, the FDA is requiring data on safety as well as efficacy for pediatric con-tact lens wear with a myopia con-trol indication. Because cases of microbial keratitis or corneal infil-trative events are rare, examining the safety of contact lens wear in children requires an exceedingly large, long-term study. Therefore, FDA approval for myopia control is not expected any time soon and

tact lenses are not FDA approved for this use is important, so an informed consent document is important. The document should clearly state that the lenses are not FDA approved for myopia control, provide a general state-ment of risk regarding contact lens wear, and indicate the evidence for myopia control. Figure 1 shows information from the informed consent document used at the Kids Contact Lens Clinic at The Ohio State Univer-sity College of Optometry. CLS

lenses used as such are done so in an off-label manner.

In light of that fact, practitio-ners should not advertise myopia control with a particular brand or even modality of contact lens. Furthermore, parents must be made aware that the contact lenses are not approved by the FDA for myopia control. It can be stated that they are approved for wear by children, but not to slow the progression of nearsight-edness in children. Acknowledg-ment by the parent that the con-


TABLE 1 Sample Consent Form InformationWe insist that parents of patients opting for any of these off-label treatments must sign a form to indicate consent before we will start treatment. Here is some of the information we would include on that form.

Corneal Reshaping–Corneal reshaping contact lenses are worn during sleep and removed in the morning. They tem-porarily change the shape of the cornea (the clear window on the front of the eye), so that the child can see clearly all day long without glasses or contact lenses. During the first two weeks of wear, your child will experience changing vision. When the vision gets worse, he may put on glasses to provide clear vision. Although the chance of an eye infec-tion is still very low (about one case per 500 years of wear), it is greater for corneal reshaping contact lenses than usual daytime contact lens wear because the contact lens is worn overnight.

Soft Bifocal–Soft bifocal contact lenses are routinely worn to help people over 40 years of age read clearly as well as see far away. Children may not see quite as clearly with these contact lenses as other types of contact lenses, but there are no additional risks compared to regular daily contact lens wear.

Atropine–Atropine is an eye drop that typically makes light seem bright because it makes the pupil (black hole in the middle of the eye) bigger, and it blurs near vision because it reduces the ability to focus the eyes while looking at near. Low concentration (0.01%) atropine has been shown to slow the progression of nearsightedness by 61% without increasing pupil size or decreasing near vision dramatically. Only 8% of children complained of problems with low concentration atropine, and glasses can reduce symptoms if your child notices poor reading vision or lights seem too bright.

Dr. Walline is an associate professor at The Ohio State University College of Optometry. His research interests primarily involve pedi-atric contact lenses and myopia control. He has received research funding from Johnson & Johnson Vision Care. You can reach him at [email protected].

Treatment PlanB Y W I L L I A M L . M I L L E R , O D , P H D , F A A O

ALearnings from the Contact Lens Discomfort Workshop

s with the Dry Eye WorkShop (DEWS) report and the International Workshop on Meibomian Gland Dysfunction (MGD) before it, the Con-tact Lens Discomfort Workshop has established

a foundation of what is known and unknown in an important di-lemma interfering with successful contact lens wear in our patients. The recently published report exhaustively covers all aspects related to contact lens-related discomfort (TFOS 2013).

One report within the com-prehensive workshop covers the treatment and management of the condition and discusses what evidence-based medicine exists for particular therapies. Level I evidence would be that which is conducted using carefully con-trolled randomized clinical trials. Level II evidence could come

as though switching to a silicone hydrogel lens may be mildly help-ful in improving comfort. How-ever, studies for both hydrogel and silicone hydrogel exist that demonstrate the effectiveness of each. The issue is related to methodologies employed by each that tend to decrease the level of evidence for individual out-comes. Parameter changes more favorable to promoting comfort include contact lens edges with a knife profile, steeper base curves and larger overall diameter lenses. The practical problem with each of these parameter changes is that typically, unless custom-made lenses are ordered, a practitioner is unable to change any of these parameters in isolation.

Wetting AgentsContact lenses with intrinsic (material laden) or extrinsic (blister pack) wetting agents are another factor used to solve CLD. No evidence exists for the use of intrinsic wetting agents in en-hancing comfort. However, Level II and III evidence exists showing that extrinsic wetting agents do increase comfortable wear, albeit short-lived in many cases.

Care SystemsLevel II evidence suggests that contact lens care system choices favor matching them with indi-vidual contact lenses types, even if the manufacturers of each are disparate. Level I evidence is conflicted with regards to particu-

from well-designed non-random-ized trials. While the lowest form of evidence would be related to case reports, descriptive reports, expert opinions and the like. An-ecdotal or personal preference modes of treatment, although im-portant, would not be considered to rise to the level of scientific rigor often considered.

Table 1 illustrates areas often chosen by eyecare practitioners to address when trying to solve contact lens discomfort (CLD) in their patients. This column will succinctly address the evidence to date regarding each category.

Initial Considerations: Replacement Schedule, Materials and ParametersReplacement frequency, mate-rial and parameter changes are often among the first areas ad-dressed when treating contact lens discomfort. The evidence to date (Level II), suggests that daily disposable contact lenses could be one way to address the discomfort problem. This may be related to the elimination of a contact lens care system. Practitioners also have distinct opinions regard-ing material choices to address CLD. On the surface, it appears

TABLE 1

Areas often addressed by an ECP when managing Contact Lens Discomfort

Replacement frequencyMaterial changeParameter changeWetting agentsContact lens care systemTear supplementsEnvironmentNutritionPunctal occlusionTopical medication


Treatment Plan

Dr. Miller is an associate professor and chair of the Clinical Sciences Department at the Univer-sity of Houston College of Optometry. He is a member of the American Academy of Optome-try and the AOA where he serves on its Journal Review Board. He is a consultant or advisor to Alcon and Vistakon and has received research funding from Alcon and CooperVision and lec-ture or authorship honoraria from Alcon and B+L. You can reach him at [email protected].

lar contact lens care system rec-ommendations to decrease CLD.

Tear SupplementsOnce contact lenses and care systems are addressed by the ECP, the next most commonly performed intervention to ad-dress CLD involves topically applied tear supplements to the contact lens and ocular surface. Most consider this the mainstay of therapy for mild to moderate degrees of CLD. Most evidence, Level II and III, concludes that this therapy is beneficial to im-proving CLD. Earlier studies indicate that even 0.9% saline could be helpful. More recent studies favor complex tear supple-ments that may include polyvinyl alcohol (PVA), carboxymethyl-cellulose (CMC) and Povidone. There is also evidence (Level II) that hydroxyl propyl cellulose (Lacrisert) inserts are helpful in improving comfort with contact lenses at least to 1 month.

Environmental ConsiderationsEnvironmental interventions, though intuitive, have little basis in published literature. Some lev-el III studies indicate that smoke, pollen, dust and low humidity should be avoided to improve comfort. Blinking behavior modi-fication to improve comfort has not been proven in the literature.

Nutritional SupplementsNutritional interventions, al-though part of clearly proven non-contact lens dry eye therapy, finds little evidence for combat-ting CLD. One Level I study showed that the use of Omega-6 improved comfort in contact lens wearers, however the study was only conducted on a cohort of

female subjects. Evidential sup-port of improving hydration lev-els to treat CLD is currently not supported by the literature.

Punctal OcclusionThe evidence supports the use of punctal occlusion to improve comfort. The occlusion should be performed with silicone plugs and both the inferior and superior puncta should be occluded.

Steroids and NSAIDs No studies exist for demonstrat-ing the use of steroids and non-steroidal anti-inflammatories for use with soft contact lens discomfort. Although Level II evidence shows that diclofenac improves comfort in RGP contact lens wearers in the early adapta-tion period. One Level I study, albeit open label, demonstrated the effectiveness of azithromycin (bid) for 1 month in improving comfort in contact lens wearers. Future research involves medica-tions that focus on neuromodula-tors such as resiniferatoxin, which target nociceptive neurons and modulate the pain response.

Check out the ReportIn conclusion, I encourage you to consult the full report to garner specific details, study references and results for each category. CLS


Prescribing for Presbyopia


adjust to simultaneous multifocal optics more easily.

A recent study exploring pa-tient performance with multifocal and monovision correction found

acuity with multifocals, both at distance and near, improved over a 15-day period (Fernandes et al, 2013). This suggests a possible adaptation of the visual system to multifocal optics over time. In-terestingly, this same study found acuity with monovision did not improve. In fact, visual perfor-mance appeared to decrease over time in some cases.

Stay CurrentStaying abreast of current litera-ture on multifocal contact lenses provides insight into why these lenses sometimes don’t perform as we’d expect. It also arms us with strategies to help deliver improved performance. CLS


Dr. Quinn is in group practice in Athens, Ohio. He is an advisor to the GP Lens Institute and an area manager for Vision Source. He is an advisor or consultant to Alcon and B+L, has received research funding from Alcon, AMO, Allergan, and B+L, and has received lecture or authorship honoraria from Alcon, B+L, CooperVision, GPLI, SynergEyes, and STAPLE program. You can reach him at [email protected].

(Continued from page 11)

Consider light level when assessing

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REFERENCES: 1. Brennan NA. A Model of Oxygen Flux Through Contact Lenses, Cornea 20(1):104-108, 2001. 2. Bergmanson J. Clinical Ocular Anatomy and Physiology. 14th ed. Houston, Texas: Texas Eye Research and Technology Center; 2007. 3. Twenty-two subjects participated in a randomized, double-masked, contralateral eye study to evaluate water loss of Biotrue® ONEday, 1-Day ACUVUE MOIST, and 1-Day ACUVUE TruEye. After 4, 8, 12, and 16 hours of wear, lenses were removed and immediately weighed (wet weight). The lenses were then completely dried and reweighed (dry weight). The percent water loss was then calculated for each lens from the wet and dry weights.

Contact Lens SPECTRUM · PDF fileGo to or contact a Bausch + Lomb sales representative today. ... Contact Lens Case Reports. Mark P. André, ... INC. ©2014 Bausch & Lomb

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