First Subject Enrolled in Trial to Confirm Safety and Efficacy of TearCare Device for Dry Eye
Sight Sciences announced the first subject has been enrolled in OLYMPIA, a US pivotal trial to further assess the safety and efficacy of TearCare for patients with dry eye disease.
TearCare is a wearable, personalized, open-eye technology that delivers regulated, localized heat to the eyelids to help clear the diseased meibomian glands of oily obstructions and restore the production of healthy clear meibum.
“At our center we are constantly looking for new technologies that create a benefit for our patients. And there are a lot of options when it comes to dry eye disease,” Vance Thompson, MD, founder of Vance Thompson Vision who enrolled the first subject in the OLYMPIA pivotal trial, said in a company news release. “What we like about the TearCare device is how it conforms to the outer eyelids, allowing patients to blink freely, and comfortably keep their eyes open throughout the entire procedure. This creates a nice experience for the patient and the team.”
OLYMPIA is a prospective, multicenter, randomized, controlled study designed to evaluate TearCare versus Lipiflow in the treatment of the signs and symptoms of dry eye disease. The trial will enroll 138 subjects across 10 centers in the United States.
“Over the past several months, we have worked diligently to select investigational sites for successful completion of the trial so the enrollment of the first subject in OLYMPIA is a significant milestone for Sight Sciences and our cutting-edge TearCare technology,” Anne-Marie Ripley, Vice President of Clinical and Regulatory Affairs at Sight Sciences, said in the news release. “We look forward to working directly with the OLYMPIA sites and completing a trial that, if successful, should provide a long-term impact in the dry eye space.”
Enrolled subjects in the trial must have meibomian gland dysfunction (MGD), which 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 pivotal trial and offer a personalized, non-invasive treatment option to my patients,” said Marc Bloomenstein, OD, FAAO, Director of Optometric Services at Schwartz Laser Eye Center. “Unlike other dry eye technologies, TearCare allows me to personalize the entire treatment, from the custom conformance of the flexible SmartLids which match a patient’s unique outer eyelids to the custom manual clearance of the meibomian glands taking into account each patient’s unique lid and gland anatomy. I am excited to study this personalized approach in my dry eye patients that suffer from MGD.”
“Our team has worked diligently over the past six years to design a system that is intended to set a new bar for dry eye therapy. This trial brings us one step closer to our vision of delivering a better dry eye treatment experience for both patients and eye care professionals,” said Paul Badawi, Co-founder and Chief Executive Officer of Sight Sciences.