Sight Sciences 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.
“We need additional treatment options for dry eye,” Edward Holland, MD, Director of Cornea Services at Cincinnati Eye Institute and Professor of Ophthalmology at the University of Cincinnati, said in a company news release. “I like several aspects of the TearCare System’s iLid device. It is noninvasive and conforms to the patient’s lid anatomy thereby individualizing and optimizing treatment and allows the patient to blink freely throughout the procedure.”
Meibomian gland dysfunction is the most common cause of dry eye disease. It occurs when the meibomian glands of the eyelids do not secrete enough oils onto the tear surface, causing tears to evaporate too quickly and leading to evaporative dry eye disease.
“I am excited to participate in the OLYMPIA trial and offer a customized, non-invasive treatment option to my patients,” Paul Karpecki, OD, FAAO, Director of Cornea Services at Kentucky Eye Institute (Lexington, KY) and Gaddie Eye Centers (Louisville, KY), said in the news release. “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.”
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.
“Over the past several months, we have worked diligently to select investigational sites for successful completion of the trial,” said Anne-Marie Ripley, Vice President of Clinical and Regulatory Affairs at Sight Sciences. “I look forward to working directly with the OLYMPIA sites and completing a trial that will provide a long-term impact in the dry eye space.”
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.
“The initiation of this study is a significant milestone for Sight Sciences and our cutting-edge TearCare technology,” said Paul Badawi, President and Chief Executive Officer of Sight Sciences. “I am truly proud of our team that has worked obsessively in stealth over the past 5 years to iterate to a final product design we think will set a new bar for dry eye therapy. Our pivotal trial brings us one step closer to our vision of delivering a first-class dry eye treatment experience for both patients and eye care professionals.”
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.