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Sight Sciences to study TearCare System for dry eye
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Sight Sciences announced the initiation of the OLYMPIA study to evaluate the safety and efficacy of the TearCare System in patients with dry eye disease.
The TearCare System is a wearable and customizable therapeutic eyelid technology that allows for the eyes to remain open and blinking during the procedure, according to a company press release.
The flexible devices conform to the eyelids to deliver a sufficient level of energy for a specific period of time to liquefy meibum. Meibomian gland dysfunction is the most common cause of dry eye disease, according to the release.
The randomized, controlled trial will evaluate the safety and effectiveness of the TearCare System in the treatment of the signs and symptoms of dry eye disease in comparison to a daily regimen of combined warm compress therapy and lid massage. The trial will enroll 200 subjects at 10 centers in the U.S.
The primary endpoint is tear breakup time at 1 month, and several other endpoints will be evaluated to assess changes in the subjects' dry eye signs and symptoms.
Treatment efficacy and safety will be assessed by following subjects for 6 months, at which point subjects will be re-treated with the TearCare System and followed another 6 months, for a combined follow-up of 12 months, according to the release.