April 10, 2018
The first contact lenses that have an additive that automatically darkens the lenses when exposed to bright light have been cleared by the US Food and Drug Administration (FDA).
The Acuvue Oasys Contact Lenses With Transitions Light Intelligent Technology (Johnson & Johnson Vision Care, Inc) are soft contact lenses indicated for daily use to correct myopia or hyperopia. They can also be used by people with certain degrees of astigmatism.
"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, Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health, said in a news release.
The contact lenses contain a photochromic additive that adapts to the amount of visible light filtered to the eye. The additive causes the lenses to darken slightly in bright sunlight. The degree of darkening is based on the amount of ultraviolet (UV) light to which the lenses are exposed. The lenses automatically return to a regular tint when exposed to normal or dark lighting conditions.
In granting 510(k) clearance to the Acuvue Oasys Contact Lenses With Transitions Light Intelligent Technology, the FDA reviewed available scientific evidence, including a clinical study of 24 patients that evaluated daytime and nighttime driving performance while wearing the contact lenses. The results showed "no evidence of concerns with either driving performance or vision while wearing the lenses," the FDA said in a news release.
According to the FDA, patients with the following conditions should not use these contact lenses: inflammation or infection in or around the eye or eyelids; any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids; any previously diagnosed condition that makes contact lens wear uncomfortable; severe dry eye; reduced corneal sensitivity; any systemic disease that may affect the eye or be made worse by wearing 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 the use of contact lens solutions; any active eye infection or red or irritated eyes.
Acuvue Oasys Contact Lenses With Transitions Light Intelligent Technology are intended for daily wear for up to 14 days. Patients should not sleep in these contact lenses, expose them to water, or wear them longer than directed by an eye care professional. They should not be used as substitutes for UV protective eyewear.
An estimated 42% of Americans aged 12 to 54 years have myopia, and 5% to 10% of all Americans have hyperopia, according to estimates from the National Eye Institute. The Centers for Disease Control and Prevention estimates that as of 2014, more than 40 million Americans wore contact lens.