contact lens care and compliance

FDA Begins to Take Action Regarding Lens Care — Part 3

BY SUSAN J. GROMACKI, OD, MS, FAAO

This is the third and final installment summarizing the Ophthalmic Devices Panel's recommendations to the United States Food and Drug Administration (FDA). Following the Fusarium and Acanthamoeba outbreaks of the past two years, the agency is working to revise testing recommendations for contact lens care products.

The FDA posed six main questions to the panel. The six points reviewed modifications to preclinical and clinical testing for contact lens care products and to product labeling.

The panel's responses to the first four questions are in the October and December 2008 Contact Lens Care columns. Here are the final two questions posed by FDA official James Saviola, OD, followed by the panel's recommendations.

Silicone Hydrogel Lenses

Dr. Saviola: "Please discuss whether you agree with ISO's (The International Standards Organization) current consideration of having silicone hydrogel lenses as a separate group and FDA's plan to further stratify the silicone hydrogel lens group into subcategories."

The panel easily recommended that silicone hydrogel contact lenses should be separated from the current FDA material classification system and further subdivided into three-to-four groups of their own.

Stand-Alone Testing

Dr. Saviola: "The current cytotoxicity test involves testing on the multipurpose solution by itself and not in conjunction with various groups of lenses. Please discuss our proposal to include both conventional and silicone hydrogel contact lenses soaked in a multipurpose solution for direct contact cytotoxicity testing to evaluate multipurpose solutions, or any care product for that matter."

The panelists unanimously concluded that FDA cytotoxicity testing to evaluate multipurpose solutions, unlike the current Stand-Alone test, should include a contact lens and contact lens case and should incorporate both conventional and silicone hydrogel lenses.

A transcript of the meeting, including the panel's complete discussion and the presentation slides from the open public hearing morning session, is available on the FDA's Web site at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=699.

What's Next for the FDA

Based on the results of the June 2008 meeting, the FDA scheduled a Contact Lens Microbiology Workshop that occurred in January. The purpose of the workshop was to help develop new test methods to evaluate the disinfection efficacy of contact lens care products for Acanthamoeba and for "real-world" or "worst-case" scenarios.

The FDA invited experts in the area of Acanthamoeba with an emphasis on care systems and microbiology. Agenda items included test methods to evaluate efficacy against Acanthamoeba and also "real-world" disinfection efficacy testing. The meeting was sponsored by the American Academy of Optometry, the American Optometric Association, the American Academy of Ophthalmology and the Contact Lens Association of Ophthalmologists. Look for a link to the meeting transcript in the online version of this column.

This is an important step for the FDA, as it is in everyone's best interest to expedite the development of new testing standards for lens care products to prevent future keratitis outbreaks among contact lens wearers. CLS

I would like to thank Jim Saviola, OD, of the FDA, for his assistance with this article.

Dr. Gromacki is a Diplomate in the Cornea and Contact Lens section of the American Academy of Optometry. She lives in West Point, New York.