Thirty-day extended wear contact lenses could experience a comeback in the United States as early as this fall.
The FDA’s Ophthalmic Devices Panel unanimously recommended approval of CIBA Vision’s Focus Night & Day contact lenses for up to 30 nights of continuous wear, provided CIBA Vision meets certain conditions. Specifically, the panel recommended modifications to the indications and labeling, and that CIBA Vision perform a post-market study to establish the rate of microbial keratitis.
Meanwhile, Bausch & Lomb has completed U.S. clinical trials on the use of its PureVision contact lens for up to 30 days of continuous wear and has applied to the FDA for 30-day approval in the United States.
Focus Night & Day, while not yet approved in the United States, is available in more than 40 countries. More than 250,000 patients are wearing the lens for up to 30 days. PureVision is approved for up to seven days of continuous wear in the United States and 30 days in Europe.
Extended wear fell out of favor in 1989, when researchers reported that the incidence of ulcerative keratitis jumped from 4.1 per 10,000 daily-wear soft contact lens wearers to 20.9 per 10,000 extended wear soft contact lens wearers.1 Manufacturers of extended wear lenses then voluntarily reduced wearing times from 30 days to seven days, and included information about the risks in the product labeling.
The lenses now under consideration, both silicone hydrogels, are designed to reduce some of the hypoxia-related risks of earlier extended-wear materials. Focus Night & Day lenses, made of lotrafilcon A, offer oxygen transmissibility of 175 Dk/t, which CIBA says is six times higher than conventional lenses. PureVision, made of balafilcon A, offers oxygen transmissibility of 110 Dk/t (at -3.00D), a rate of five times that of conventional soft lenses, B&L says.
Clinical studies on PureVision lenses have shown reduced corneal swelling, no significant increase in bacterial binding to epithelial cells and no corneal edema. Studies on Focus Night & Day have shown that patients had a pattern of limbal hyperemia similar to that of non-lens wearers, 2 and that there was no significant bacterial buildup even after 30 nights of continuous wear. (For more on these and other studies, see “25th Annual Contact Lens Report: Safer, Healthier, Longer,” April 2001.)
The next step: The FDA will consider the panel’s recommendation as it reviews CIBA Vision’s premarket approval application for Focus Night & Day. The FDA is expected to make its decision as early as the fall.
1. Poggio EC, Glynn RJ, Schein OD, et al. The incidence of ulcerative keratitis among users of daily-wear and extended-wear soft contact lenses. N Engl J Med 1989 Sep 21;321(12):779-83.
2. Papas EB, Vajdic CM, Austen R, Holden BA. High-oxygen transmissiblity soft contact lenses do not induce limbal hyperaemia. Curr Eye Res 1997;16:942-8.