FDA today approved Focus Night and Day soft contact lenses, made by CIBA Vision Corporation, for up to 30 nights of continuous wear. The lenses may be left in the eyes while the wearer is both awake and asleep. Currently contact lenses are approved for up to seven days extended wear.
Focus Night and Day lenses may be prescribed for either daily wear or for extended wear up to 30 nights. The lenses should be replaced every month, as recommended by the eye care professional. When removed in between replacement times, the lenses should be cleaned and disinfected before reinsertion, or disposed of. Once lenses are removed, eyes should have a rest without lens wear for at least one night.
FDA based approval of the longer wear schedule on a clinical study of safety and effectiveness conducted by CIBA Vision at 59 medical centers in the United States and on the recommendation of the Ophthalmic Devices Panel of FDA’s Medical Devices Advisory Committee.
The firm, located in Duluth, Ga., studied 697 people over one year who wore the Focus lenses for up to 30 nights of continuous wear before replacing them. The company compared these results with 698 people who wore a different brand of soft contact lenses approved for up to six nights of continuous wear before replacing them.
Not everyone with the 30-day lenses reached and maintained the maximum wear time of 30 continuous days and nights for the entire one-year study period. Maximum wear time is strongly influenced by individual response to lens wear. About 67% achieved an average wearing schedule of 22 to 31 days wearing the Focus lenses. Approximately 93% of patients with the Focus lenses who completed the one-year study achieved at least 20/25 vision.
About 5% of the 697 people who began the 30 night extended wear arm of the study experienced at least one episode of infilrative keratitis, a localized inflammation of the cornea. Other less serious problems included conjunctivitis, dry eyes and mild burning or stinging.
Although no corneal ulcers occurred with the Focus Lens during the study, CIBA Vision will conduct a post-marketing study to determine the potential long-term risk of developing serious eye infections, such as corneal ulcers, from wearing the lenses up to 30 nights continuous wear.
All extended wear contact lenses carry a greater risk of serious complications than lenses worn during waking hours only. These risks include corneal ulcers that may develop rapidly and, if left untreated, cause scarring or, in rare cases, loss of vision. The risk of developing corneal ulcers during extended wear is greater for smokers. In addition, some medications and medical conditions can interfere with overnight contact lens wear. Patients should, therefore, carefully discuss the benefits and risks of extended wear lenses with their eye care professional.
People should never wear their contact lenses for longer periods than recommended by their eye care professional. They should immediately remove their lenses and promptly contact their eye care professional if they experience eye discomfort, foreign body sensation, excessive tearing, vision changes, redness or other eye problems. Follow-up care and periodic checkups are also essential to decrease the risk of complications.
