The approval follows a review of scientific evidence, including a clinical study of 24 patients that evaluated daytime and nighttime driving performance while wearing the lenses.
The FDA has approved the first contact lens with light-adaptive technology. The Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology are soft contact lenses that automatically darken when exposed to light.
A Johnson & Johnson Vision Care, Inc, product, the lenses are indicated for daily use to correct vision for nondiseased individuals with hyperopia or myopia conditions. The transitioning lenses can also be used by individuals with certain degrees of astigmatism, according to the FDA.
“This contact lens is the first of its kind to incorporate the same technology that is used in eyeglasses that automatically darken in the sun,” Malvina Eydelman, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health, said in a statement.
The newly approved contact lenses contain a photochromic additive that adapts the amount of visible light filtered to the eye based on the amount of ultraviolet (UV) light to which they are exposed. This results in slightly darkened lenses in bright sunlight that automatically return to a regular tint when exposed to dark or normal lighting conditions.
The FDA approval announced Tuesday followed a review of scientific evidence, including a clinical study of 24 patients that evaluated daytime and nighttime driving performance while wearing the contact lenses. The results of the study demonstrated that there was no evidence of concern with either driving performance or vision while wearing the lenses.
Patients with the following conditions should not use these contact lenses: allergic reactions on the surface of the eye or surrounding tissues that may be induced or made worse by wearing contact lenses or use of contact lens solutions; any abnormality, eye disease, or injury that affects the conjunctiva, cornea, or eyelids; any active eye infection; any previously diagnosed condition that makes wearing contact lenses uncomfortable; any systemic disease that may affect the eye or be made worse by wearing contact lenses; infection or inflammation around the eye or eyelids; irritated or red eyes; reduced corneal sensitivity; or severe dry eye.
These contacts are intended for daily wear for up to 14 days. Patients should not expose the contact lenses to water, sleep in them, or wear them longer than directed by an eye care professional. These contacts should not be used as substitutes for UV protective eyewear.
The National Eye Institute at the National Institutes of Health estimates that 5% to 10% of all Americans have hyperopia and 42% have myopia. The CDC estimates that, as of 2014, more than 40 million Americans wore contact lenses.
FDA clears first contact lens with light-adaptive technology [news release]: FDA; April 10, 2018. fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604263.htm. Accessed April 10, 2018.