Sight Sciences today announced positive results from a clinical trial of its TearCare wearable eyelid technology.
The Olympia study was a prospective, randomized multicenter trial that enrolled 235 dry eye patients across 10 sites in the U.S. The goal was to demonstrate the safety and effectiveness of a single TearCare procedure compared to the LipiFlow Thermal Pulsation System in treating signs and symptoms of dry eye disease.
Study results showed that a single TearCare treatment was able to safely and effectively achieve clinically meaningful improvements in all signs and symptoms of dry eye disease. Improvement in signs included tear break up time, meibomian gland secretion score and corneal and conjunctival staining. Symptom improvement included ocular surface disease index score, symptom assessment in dry eyes score and eye dryness score.
The company reported a significantly greater proportion of TearCare patients that had clinically meaningful symptomatic relief compared to LipiFlow. About 72% of TearCare patients reported symptomatic relief compared with 59% of LipiFlow patients who improved by at least one ocular surface disease index score. TearCare patients also required 22% less lubricant drops than other patients in the study.
Sight Sciences reported minor adverse events in seven TearCare subjects and nine Lipiflow subjects in the study. The adverse events were resolved without needing 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,” VP of clinical development Kavita Dhamdhere said in a 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,” Jennifer Loh, practicing ophthalmologist in Miami, said. “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.”