Sight Sciences announced new dry eye clinical data from a multicenter trial of TearCare, the first wearable eyelid technology for dry eye. Data from the study were presented at the American Society of Cataract Refractive Surgery (ASCRS) Virtual annual meeting by Jennifer Loh, MD, practicing ophthalmologist at Loh Ophthalmology in Miami, Fla.
The OLYMPIA study, a prospective, randomized multicenter trial, enrolled 235 dry eye patients at 10 U.S. sites. The trial was designed to demonstrate the safety and effectiveness of a single TearCare procedure compared to a single LipiFlow Thermal Pulsation System (Johnson & Johnson) procedure in treating the signs and symptoms of dry eye disease.
Results from the study found that a single TearCare treatment safely and effectively achieved clinically meaningful improvements in all signs and all symptoms of dry eye disease (i.e., all P values <0.01). Improvement in signs include: tear break-up time, meibomian gland secretion score, and corneal and conjunctival staining. Improvement in symptoms include: ocular surface disease index score (OSDI), symptom assessment in dry eye score (SANDE) and eye dryness score (EDS). The non-inferiority objectives for the primary endpoints, tear break-up time and meibomian gland secretion scores, were met. Markedly, a significantly greater proportion of TearCare patients showed clinically meaningful symptomatic relief compared to LipiFlow patients, with 72% of TearCare vs. 59% of LipiFlow subjects improving by at least one OSDI category, according to a Sight Sciences news release. As a result of their significant symptomatic improvement, TearCare subjects required 22% less lubricant drops than LipiFlow subjects throughout the study. Adverse events reported in the study were minor (seven in the TearCare group and nine in the LipiFlow group), and resolved without requiring any further treatment.
“The positive signs and symptoms findings from the OLYMPIA trial adds to the growing body of evidence showing that the first-of-its-kind TearCare procedure is a truly effective treatment for meibomian gland dysfunction and dry eye disease,” Kavita Dhamdhere, MD, PhD, Vice President of Clinical Development at Sight Sciences, said in the news release. “As the leading cause of visits to an eye care provider, dry eye disease can damage the ocular surface and cause great discomfort for patients. We are particularly excited about two key findings from our pivotal trial: first, that a single TearCare treatment delivered clinically meaningful and statistically significant improvements across the board for all dry eye signs and symptoms, and second, that there was a clinically meaningful percentage of TearCare patients (72% TearCare vs. 59% LipiFlow) who experienced significant symptomatic benefit.”
“Dry eye is an increasingly common disease, and there is a significant unmet need for an effective treatment that provides significant symptomatic relief,” said Dr. Loh. “Having used TearCare for the past year, I have found that the procedure delivers rapid results and consistently high effectiveness for my dry eye patients. It is exciting and encouraging to see that the results of this randomized controlled trial are consistent with my real-world experience and underscore the reason I offer TearCare to my patients—notably that TearCare delivers more symptomatic relief for patients than any other options in this category, as evidenced by an unprecedented and high rate of subjects (72%) whose symptoms had clinically meaningful improvement by at least one OSDI category within a month.”