contact lens care
FDA Begins to Take Action Regarding Lens Care — Part 1
BY SUSAN J. GROMACKI, OD, MS, FAAO
In the wake of the Fusarium and Acanthamoeba keratitis outbreaks reported in the last two years, the United States Food and Drug Administration (FDA) has taken initial steps to more strictly regulate contact lens care products and practices. A June 10, 2008, session began with an Open Public Hearing in which the public was given an opportunity to provide testimony. Eighteen presenters — including academic researchers, practicing clinicians, professional society representatives and industry personnel — spoke for eight minutes each.
In the afternoon, the FDA sought advice from its Ophthalmic Devices Panel, a neutral group of experts, regarding modifications to preclinical and clinical testing for contact lens care products and product labeling. The FDA came forth with six very specific questions. The first two questions, presented in their entirety as posed at the meeting, are listed below along with the panel's recommendations.
The first question as stated by Jim Saviola, OD, of the FDA: "Please discuss whether our proposed directions for use and warnings are warranted. If yes, please identify any other messages that should be conveyed in the proposed warnings. Then there are five sub parts, regarding reuse and topping off is the first one, (b) is rub and rinsing times, (c) is lens case care, (d) is water activities and (e) is specifying a lens care product discard date. And also please provide any other additional recommendations for product labeling that you may have."
The panel concurred that patient noncompliance does affect proper lens care. Dr. Myra Smith of the FDA's Division of Ophthalmics and ENT devices stated that, "We know that people are going to do these things," but that the panel's or FDA's recommendations should not be swayed by whether a patient will comply with instructions.
The panel went on to recommend that a lens care product label should include a warning against "topping off" or reusing solution. In addition, both rubbing and rinsing should be part of product instructions, but there is not enough data at this time to specify an exact rinsing time. Lenses should not be stored in water or in any kind of non-sterile solution. Frequent case replacement should be specified, but additional research is needed to determine the exact time interval. A solution label should include a warning against wearing lenses during water activities (although the panel did not come to a consensus regarding the exact wording). A lens care product discard date after opening (as in Europe) would be welcomed, although logistically difficult for patients to follow.
Dr. Saviola: "Currently, rub and no-rub care products have been cleared by the FDA for marketing in the United States. In light of all the data currently available, please discuss your recommendations for continuing to have no-rub directions in the product labeling."
The panel concluded that instructions should include both rub and rinse steps for existing care products. "Rinsing works somewhat, rubbing works even better. The combination of the two is best of all, and not doing either is worst of all," said Timothy McMahon, OD. The panel mentioned that the FDA should not ban the opportunity for no-rub, to encourage industry to create more effective products in the future.
My next column will discuss how the panel responded to the FDA's remaining four questions. CLS
Dr. Gromacki is a Diplomate in Cornea and Contact Lenses in the American Academy of Optometry. She lives in West Point, New York.