EYE CARE NEWS

The FDA Ophthalmic Devices AdvisoryPanel met on June 10, 2008, in Washington,D.C., to propose recommendations for theagency to improve the safety and effective-ness of contact lens care products. AMOpresented recommendations to the panel.FDA decisions have yet to be released.Typically, the agency follows its panel’s rec-ommendations. The following are some ofthe recommendations presented to thepanel.

Change the Compliance ParadigmBernard P. Lepri, OD, MS, MEd of the

FDA/Center for Devices and RadiologicalHealth, Office of Device Evaluation, showedcontact lens care as a subset of the well-known and costly problem of compliance.Noncompliance is higher in complex treat-ment regimens and asymptomatic healthconditions.

One in four physician visits in the year2000 resulted from not following the physi-cian’s treatment regimen.1 In a study of col-lege students and healthcare workers, onlyone or two of every four patients adheredconsistently to the practitioner’s instruc-tions for contact lens care.2 Dr. Lepri report-ed that 80% of contact lens complications

can be traced to inappropriate wear andpoor lens care.

The special challenge for contact lensmanufacturers, said Lepri, is moving awayfrom seeing compliance as an error on thepart of the patient and, instead, designingthe product for ease of use by the wearer.Contact lens care products should bedesigned and tested with consumer usepatterns in mind.

Improve the Warnings on LabelsCarol Clayton, from the FDA Center for

Devices and Radiological Health, Office ofCommunication, Education and RadiationPrograms, proposed new labeling for con-tact lens care products. The panel dis-cussed a Rub and Rinse regimen with new,more readable, labeling on the contact lenscare packages and bottles.

Improve Testing RegimensSimon Kilvington, PhD, of the

Department of Infection, Immunity andInflammation at the University of Leicester,England at the time, described the tropho-zoite and cyst forms of Acanthamoeba. Theagent causes potentially blinding infectionof the cornea in otherwise healthy persons.

Dr. Kilvington discussed the biocidalefficacy of contact lens care solutions andthe regimens to remove deposits that devel-op on the lenses. He concluded that thecontact lens industry needs to address therisk of infection through education, promot-ing the rub step and extended disinfectiontimes. Dr. Kilvington has since joined AMOas director of microbiology.

AMO continues tolead the industry withnew products and serv-ices to help yourpatients. We’ve had

firsts in the last 50 years before and after wespun off from other companies. Now AMOagain leads in contact lens care regimens toprovide compliance systems to support effec-tive contact lens cleaning.

On June 10, 2008, the FDA convened apanel to discuss new requirements for contactlens solutions in the wake of product recalls byBausch & Lomb and AMO. Presentations weredelivered by the FDA, the CDC and interestedmembers of the industry during a public inputsession. There were 18 public presentations,including representatives from the AmericanAcademy of Ophthalmology, the AmericanSociety of Cataract and Refractive Surgery,Cornea Society, and Contact Lens Associationof Ophthalmologists; American Academy ofOptometry Cornea and Contact Lens Section;American Optometric Association Contact Lensand Cornea Section and independent ophthal-mologists and optometrists.

So, what’s the conclusion of these recom-mendations?

■ AMO is the clear industry leader in rec-ommending more specific testing guidelinesfor contact lens care products.

■ AMO is the only manufacturer toendorse the position on rubbing the lenses thatis consistent with the recommendations ofmajor professional associations.

■ COMPLETE® MPS EASY RUB® Formula

FDA Panel Seeks Solutions toContact Lens Care

“Contact lens productsshould be designed and tested with consumer usepatterns in mind.”

— Bernard P. Lepri, OD, MS MEd

continued on page 2

Leading theChange inContact Lens Care

Continued on page 2

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Redesign Procedures to Reflect Actual Use and Misuse

Doyle Stulting, MD, PhD, professor ofophthalmology, and director of the section ofcornea and external disease at EmoryUniversity in Atlanta, Ga., advocated changesin the policies and procedures for theapproval and labeling of contact lens careproducts. Dr. Stulting recommended that theFDA review its procedures for testing contactlens disinfection products.

“These procedures should be redesignedto reflect conditions of actual use and mis-use, including a methodology for testing theability of the solutions to support the replica-tion of microbes in drying films, and underconditions in which patients top off their dis-infection solution. They should not onlyinclude a variety of microbes likeAcanthamoeba, but also a variety of contactlens polymers, like silicone hydrogels, todetermine whether interactions with thesepolymers themselves might reduce the effi-cacy of the disinfection products.”

Dr. Stulting urged the panel to emphasizeefficacy rather than convenience. “The firstsuch change should be the removal of the norub claim, because rubbing contact lenses isa scientifically proven way to improve theefficacy and the safety margin of modern dis-infection solutions.” Dr. Stulting recommend-ed the launch of a national campaign to raiseawareness about good contact lens carepractices and the appropriate and responsi-ble use of contact lenses.

Use Rub and Rinse for All ProductsThe panel recognized Rub and Rinse as

the standard for proper cleaning and disin-fecting of contact lenses. “I think that if rub-bing gives you one log unit, it’s worth it,” saidWilliam D. Mathers, MD, “and it doesn’t meanthat you can’t have an effective solution thatgives you more log units, but an additional logunit of efficacy is worth it for a rub.”

Acting Chairperson Neil M. Bressler, MD,commented, “Given what we’ve heard aboutcompliance, then maybe an additional factorto take into consideration is that we all heardgood data to support rubbing and rinsingwith the solution.”

Timothy McMahon, OD, added, “To sum-marize, rinsing works somewhat; rubbingworks even better. The combination of the twois best of all and not doing either is worst ofall.” He said to the panel, “We can en-courage rub and rinse now so this particularapproach re-emerges, and we can urge thatthe notion of no-rub go away as benchmarksare established.”

FDA Panel Seeks Solutions to Contact Lens Care (cont.)

is the only solution to incorporate Rub andRinse in its instructions.

■ AMO initiated and supports theremoval of “No Rub” from labels on contactlens care products.

The growth of the contact lens industryhas been flat for years. Approximately 7% ofnew wearers enter the market each year andthe same percentage discontinue their con-tact lenses. One reason that patients quit isdiscomfort. Contact lenses with protein de-posits can irritate the cornea. Rubbing andrinsing help break up the deposits.

We know the stories of patients usingsaline solution or water to clean their lenses oradding new contact lens solution to old in amisguided attempt to make the bottle last aslong as possible. We need to remind allpatients, “Always use fresh solution.” Onlyfresh solution has the full complement ofcleaning and disinfecting agents.

Good hygiene should be modeled in the of-fice. Recommend that patients routinely tradein their old contact lens case for a new one.Demonstrate good hand-washing technique.Demonstrate how to clean the contact lens toremove microscopic irritants from the surfaceby cleaning the lenses in an outward, ratherthan a circular, motion.

It’s up to all of us in the industry, includ-ing contact lens and care product companies,practitioners and staff to join together inencouraging patients to follow the cleaningguidelines. If we can improve patient compli-ance, we may be able to make these wonder-ful healthcare devices more appealing. To-gether we can improve ocular health care.

Sincerely,

David W. Hansen, OD, FAAO (DipCL)Director, Global Professional ServicesDavid.hansen@amo-inc.com

“Rubbing contact lenses is ascientifically proven way toimprove the efficacy and safety margin of modern disinfection solutions.”

— Doyle Stulting, MD, PhD

The full transcript of the meeting is available in four parts at:fda.gov/ohrms/dockets/ac/08/transcripts/2008-4363t1-01.pdffda.gov/ohrms/dockets/ac/08/transcripts/2008-4363t1-02.pdffda.gov/ohrms/dockets/ac/08/transcripts/2008-4363t1-03.pdffda.gov/ohrms/dockets/ac/08/transcripts/2008-4363t1-04.pdfSlides presented at the meeting can be found at:fda.gov/ohrms/dockets/ac/08/slides/2008-4363s1-00-index.html

References 1. DiMatteo, MR. Variations in patients’ adherence to medical recommendations: A quantitative review of 50 years of

research. Med Care. 2004:42:200–209.2. De Oliveira PR, Temporini-Nastari ER, Ruiz Alves M, Kara-Jose N. Self-evaluation of contact lens wearing and care by col-

lege students and health care workers. Eye Contact Lens. 2003;29:164–167

Leading the Change in Contact Lens Care Continued from page 1

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Advanced Medical Optics, Inc. hasentered into a collaboration with the Institutefor Eye Research (IER) to develop contactlens disinfectant and cleaning solutions andrelated products. IER has headquarters inSydney, Australia.

IER is a nonprofit research organizationthat conducts collaborative and contractresearch with and for industry in the area ofvision correction, eye care, the anterior eye,contact lenses, contact lens care and patientmanagement to avoid contact lens complica-tions. The organization is a world leader inthe in vitro and clinical evaluation of siliconehydrogel lenses and their interaction withcontact lens care products using their propri-

etary modeling systems and databases. “IER’s world-class scientists and clini-

cians have had a major impact on the devel-opment of contact lenses and lens care tech-nologies,” said Leonard Borrman, AMO’sexecutive vice president, research and devel-opment. “We look forward to working closelywith the IER on the development of next-gen-eration contact lens solutions.”

“Through our collaboration with AMO, wewill work to develop, test and deliver, throughproduct innovation and education, the best incontact lens care products,” said IER CEOBrien Holden, PhD. “Our goal is to developnew, safer, better and more convenient initia-tives in the field of contact lens cleaning and

disinfection systems, including the contain-ers for storage, cleaning and disinfection.”

Institute for Eye ResearchThe Institute for Eye Research is dedicat-

ed to “Vision excellence for all people.” Formore than 20 years, the institute has collab-orated with the world's leading researchersto bring innovation in vision. An Australiannot-for-profit organization, IER has grown tobe a major participant and supporter ofresearch worldwide and is committed to theadvancement of vision science and the provi-sion of sustainable eyecare services andeducation in developing communities. Formore information please go to ier.org.au.

A M O N E W S

AMO Partners With Institute for Eye Research to DevelopContact Lens Disinfectant and Cleaning Solutions

Did You Know? ■ Dry eye syndrome is a common disorder

of the eye’s tear film and affects millions of peo-ple worldwide.

■ Dry eye syndrome is the most commontreatable eye disorder in North America and is aconfounding factor in a wide variety of eye diseases.

■ One in four ophthalmic patients reportdry eye symptoms.

■ Women are twice as likely as men to suf-fer from dry eye.

■ Dry eye syndrome is often associatedwith other diseases, such as diabetes and auto-immune diseases.

■ Dry eye syndrome is prevalent duringmenopause

■ Dry eye syndrome impacts up to 11% ofthose between 30 and 60 years of age and upto 14% of people over age 65.

■ For more information on dry eye, visityourhealthyeyes.com.

AMO TeachingMaterials for theClinician’s OfficeAMO has developed patienteducation materials on contact lens hygiene and compliance for the clinician’soffice. Contact your sales representative or AMO customer service at800.821.1515.

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0905OM

Published December 2008The e-mail version of this newsletter is available at: lwwvisioncare.com/emails/amo/newsletter05/issue12/2007.12.10 - EC184 1208 OM-338

Blink® Tears Lubricating Eye Drops are already favorites among lead-ing optometrists and ophthalmologists who treat patients with dry eyesyndrome. Two new products to the family of Blink® Tears are BlinkGelTears® Lubricating Eye Drops and Blink® Tears Preservative-Free. Bothare made from a unique, viscoadaptive formula to treat the symptoms ofdry eye. This formula has a blend of ingredients found naturally in the eye.

Blink GelTears® Lubricating Eye Drops: ■ Provides all the advantages of Blink® Tears but

with a more viscous formula specially designed forenhanced comfort in moderate-severe dry eyepatients

■ Provides longer-lasting relief for daytime andnighttime use

■ Adapts to an individual’s dry eye needs bythickening when the eye opens and thinning when the eye closes

■ Restores the tear film with every blink ■ Improved tear film stability ■ Dissipating preservative in the eye.

Blink® Tears Preservative-Free Lubricating Eye Drops: ■ Blink® Tears Preservative-Free is the only preservative-free eye

drop that adapts to patients’ dry eye needs and provides satisfying,

longer-lasting relief without blurring,while also promoting the health andwell-being of the eye

■ Greater than 60 minutes retentiontime1

■ Significant improvement in com-fort and vision quality over time2

■ Significantly less blur vs.Systane® drops2

■ Patients preferred Blink® Tears vs. previous eye drops ■ Blink® Tears Preservative-Free is safely provided to patients with

allergies, sensitive eyes or post-LASIK in a sterile, single-use vial.2

References

1. Data on file, 2007, Interferometry clinical study. Advanced Medical Optics, Inc., Santa Ana, CA

2. Data on file, 2007. Donnenfeld ED, Ophthalmic Consultants of Long Island, Rockville Center, NY

Blink Tears Product Family ■ The family of Blink® Tears products is now available over

the counter to help the estimated 55 million Americans whosuffer from occasional or chronic dry eye.

■ AMO launched Blink® Tears in Europe in June 2008.

Product News

COMPLETE, EASY RUB, Blink and Blink GelTears are registered trademarks ofAdvanced Medical Optics, Inc. Systane is a registered trademark of Alcon, Inc. © 2008 by Advanced Medical Optics, Inc. 2008.09.18-CN623.

Advanced Medical Optics | 1700 E. St. Andrew Place, Santa Ana, CA 92705 |800.347.5005

“I’ve been impressed that Blink Tears unpreserved drops gives patients the bestvision correction and the fewest complaints of any other dry eye drops.”

Jim Owen, OD, FAAO – La Jolla, CA

“Blink epitomizes what clinicians and patients are looking for in a dry eye treat-ment — it’s comfortable, gentle, long-lasting, and doesn’t interfere with vision.”

Michael DePaolis, OD, FAAO – Rochester, NY

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