OLYMPIA is a prospective, randomised multicenter clinical study that enrolled 235 dry eye patients at ten sites across the US
US-based medical device company Sight Sciences, has unveiled new clinical data from a clinical trial of TearCare, a wearable eyelid technology for treating dry eye.
The clinical trial, dubbed OLYMPIA is a prospective, randomised multicenter study that enrolled 235 dry eye patients at ten US sites.
The study is designed to demonstrate the safety and effectiveness of a single TearCare procedure compared to a single LipiFlow Thermal Pulsation System, to treat the symptoms of dry eye disease.
Sight Sciences clinical development vice president Kavita Dhamdhere said: “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.
“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 who experienced significant symptomatic benefit.”
TearCare is the first wearable and intelligent eyelid technology for treating dry eye
TearCare is said to be the world’s first wearable and intelligent eyelid technology for treating dry eye. The device combines the company’s wearability, total tarsal conformance, blink assistance, and software-sensor controlled thermal optimization technologies.
In addition, TearCare would safely, consistently, and non-invasively achieves and maintains the elevated tarsal conjunctival temperatures required to melt and clear gland obstructions thereby restoring the critical oil-producing function of the meibomian glands within the eyelid.
The study results showed that the TearCare treatment has safely and effectively achieved clinically meaningful improvements in all signs and all symptoms of dry eye disease.
The improvement in signs includes tear break-up time, meibomian gland secretion score, and corneal and conjunctival staining, while improvement in symptoms include ocular surface disease index score (OSDI), symptom assessment in dry eye score (SANDE) and eye dryness score (EDS).
The clinical study has met the non-inferiority objectives for the primary endpoints, including the tear break-up time and meibomian gland secretion scores.
Loh Ophthalmology practicing ophthalmologist Jennifer Loh said: “Dry eye is an increasingly common disease, and there is a significant unmet need for an effective treatment that provides significant symptomatic relief.
“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.”