FDA Approves 30-Night Continuous-Wear Contact Lenses

FDA Talk Paper

Focus Night and Day lenses have been approved by the FDA for 30 days of continuous (day and night) wear. Up until now, the longest-wearing continuous lens had been approved for up to seven days of extended wear. A study compared 697 people wearing the Focus lenses with 698 people wearing a different brand of soft lenses approved for up to six nights of continuous wear. Although not all 697 people tested using the Focus lenses for one year were able to achieve the maximum wear time of 30 days, about 67 percent were able to wear the lenses for anywhere from 22 to 31 days straight. Of the 697 people tested using the 30-night extended-wear contacts, approximately 5 percent suffered at least one incident of a localized inflammation of the cornea. Others experienced less serious problems such as conjunctivitis, dry eyes, and mild burning or stinging. Eye care professionals can prescribe the new Focus Night and Day lenses for daily wear or for extended wear up to 30 nights. Because all extended-wear contacts present a greater risk of complications than lenses worn only while awake, it is important for all patients to carefully discuss the benefits and risks of this product with their eye care professionals. Patients should never wear extended contacts for longer than recommended by their eye care professionals. After removing the contacts, patients should carefully clean and disinfect lenses before returning them to their eyes. It's a good idea to let eyes rest for at least one night once the lenses have been removed. A post-marketing study will be conducted to determine the potential long-term risks of wearing extended lenses for up to 30 nights. To view the entire article, go to: www.fda.gov/bbs/topics/ANSWERS/2001/ANS01109.html Return to Top