Growth-stage medical device company Sight Sciences has announced the initiation of the OLYMPIA study, a pivotal trial to evaluate the safety and effectiveness of the TearCare® System in patients with dry eye disease. The TearCare® System is the world's first and only wearable therapeutic eyelid technology that is fully customizable and allows the patient's eyes to remain open and blinking during the procedure. Soft, flexible powered devices conform to the eyelids to deliver a sufficient level of energy for a specific period of time to liquefy meibum, an oily coating on the eye surface which prevents tear film evaporation.
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 United States. 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. The long-term safety and effectiveness of the TearCare® treatment will be assessed by following subjects out to 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.
"We need additional treatment options for dry eye. I like several aspects of the TearCare® System's iLid™ device. It is non-invasive and conforms to the patient's lid anatomy thereby individualizing and optimizing treatment and allows the patient to blink freely throughout the procedure," said Edward Holland, MD, Director of Cornea Services at Cincinnati Eye Institute and Professor of Ophthalmology at the University of Cincinnati.
"Unlike other dry eye technologies, the TearCare® System is a smart and wearable solution that automatically regulates and maintains sufficiently elevated therapeutic temperatures for a sufficient period of time to effectively melt meibum. I can further customize the procedure by using the TearCare® specialized instrument to manually, fully clear the meibomian glands of melted meibum," said Paul Karpecki, OD, FAAO, Director of Cornea Services at Kentucky Eye Institute (Lexington, KY) and Gaddie Eye Centers (Louisville, KY).
Drs. Holland and Karpecki are two of the eye care professionals who have had the opportunity to use the TearCare® System during the process of trial site selection.
The OLYMPIA trial will follow a pilot study which demonstrated a significant increase in tear breakup time, reduction in corneal and conjunctival staining and improvement in patient symptoms following TearCare® treatment. Results from the pilot study have been published in April in the peer-reviewed journal Clinical Ophthalmology.
See the full press release here.