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First Subject Enrolled in Large, Multi-Center Pivotal Trial to Confirm Safety and Efficacy of TearCare® in the Treatment of Signs and Symptoms of Dry Eye Disease
MENLO PARK, Calif., June 13, 2019 /PRNewswire/ -- Sight Sciences, Inc., a growth-stage medical device company transforming the two fastest growing segments in ophthalmology and optometry, glaucoma and dry eye, today announced the first subject has been enrolled in OLYMPIA, the U.S. pivotal trial to further assess the safety and efficacy of TearCare® for patients with dry eye disease.
TearCare® is the only 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, the oil that forms the outermost layer of tears and helps prevent accelerated tear evaporation.
Vance Thompson, M.D., the founder of Vance Thompson Vision who enrolled the first subject in the OLYMPIA pivotal trial said, "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. 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, multi-center, 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," said Anne-Marie Ripley, Vice President of Clinical and Regulatory Affairs at Sight Sciences. "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, O.D., 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.
TearCare® is a tool indicated for the application of localized heat when the current medical community recommends the application of a warm compress to the eyelids. Such applications would include Meibomian Gland Dysfunction (MGD), Dry Eye, or Blepharitis.
About Sight Sciences
Founded in 2011, Sight Sciences is a commercial-stage medical device company dedicated to the development of intelligently designed and engineered products that address the underlying physiology of ophthalmic diseases. The company's surgical glaucoma product portfolio features the OMNI® Surgical System. Its non-surgical dry eye product portfolio consists of TearCare® for ophthalmologists and optometrists. For more information, please visit sightsciences.com.
TearCare® is a registered trademark of Sight Sciences and SmartLids™ is a trademark of Sight Sciences. All rights reserved.
All third-party trademarks are the property of their respective owners.
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SOURCE Sight Sciences