This is an overview of the US contact lens (CL) postmarket surveillance systems and surveillance study results that include silicone hydrogel CLs. As 30-night continuous wear silicone hydrogel and rigid gas-permeable (RGP) CLs were approved for use in the United States in 2001, the Food and Drug Administration (FDA) mandated large postmarket surveillance studies to assess the risk of microbial keratitis with those products when worn with the 30-night wearing schedule. Since the time of the approvals, RGP 30-night wear has been used sparingly and a shift from 30-night wear has occurred for silicone hydrogel lenses. Several silicone hydrogel lenses have been approved and most of these lenses are being prescribed for daily or flexible wear and not for 30-night wear. With daily wear and less overnight use, silicone hydrogel lenses are regularly exposed to lens care products, lens cases, and improper handling, all of which may introduce sources of microbial contamination that could trigger lens-related complications. This summary of CL postmarket surveillance system and methods gives results of FDA-mandated surveillance and of recent US studies that observed “real-world” populations for safety results outside the bounds of highly controlled prospective clinical trials.
Clinical Trial Consultant (R.L.C.), Atlanta, GA; Foresight Regulatory Strategies, Inc. (W.G.), Wilmington, MA.
Address correspondence and reprint requests to Robin L. Chalmers, O.D., Clinical Trial Consultant, 2097 East Lake Road, Atlanta, GA 30307; e-mail: Chalmers2097@gmail.com
R.C. received an honorarium from CLAO for presenting the paper at the SiHy symposium (Silicone Hydrogel Lenses - Ten Years Later) and preparation of the manuscript for this special issue of Eye & Contact Lens.
The authors have no conflicts of interest to disclose.
Lenses used for overnight wear are approved, and those used for daily wear and contact lens care products are considered cleared by FDA Regulations. For the purpose of this article, the term approved will be used for the products that have been cleared.
Accepted November 05, 2012