Sight Sciences Announces Completion of Enrollment in SAHARA, a Randomized Clinical Trial of the TearCare System vs Restasis
Sight Sciences announced the completion of enrollment in the SAHARA trial, a study designed to evaluate whether an interventional dry eye procedure with the TearCare System is superior in alleviating the signs and symptoms of dry eye disease compared to 6-months of twice daily Restasis dry eye eye drops (cyclosporine ophthalmic emulsion, 0.05%). Primary endpoints measured by a masked assessor at 6 months include changes from baseline of Tear Breakup Time (sign) and Ocular Surface Disease Index Score (symptom). Results from the 310-patient, 1:1 randomized SAHARA trial are expected to be available in late Q2 2023.
“While topical prescription therapies play an important role in the treatment of dry eye disease, we believe the interventional TearCare procedure may be a more effective treatment for this chronic disease, based on its fast onset of action, consistent improvements in dry eye signs and symptoms, and durability of treatment effect that we have seen through other TearCare trials and regular clinical use. We are looking forward to comparing the TearCare procedure to daily cyclosporine use in all of these clinically important ways through this RCT,” Brandon Ayres, MD, FAAO, Co-Director Cornea Fellowship Program, Wills Eye Hospital, said in a company news release. “We look forward to the 6-month results of this landmark “device vs drug” trial for patients suffering from dry eye disease and think it could have major implications in how we think about and treat dry eye disease going forward.”
SAHARA is the first multicenter, randomized controlled trial designed to evaluate whether treatment with a dry eye therapeutic device (TearCare) demonstrates superiority when randomized against a standard of care dry eye prescription topical medication (Restasis). Patients in the TearCare group underwent an in-office eyelid debridement, 15-minute bilateral, precision controlled thermal session with TearCare, immediately followed by physician guided manual expression of the meibomian glands. Patients in the Restasis control group self-administered 1 drop of Restasis twice a day every day for 6 months with clinical assessments completed at the 6-month timepoint. The primary superiority endpoint measures to be evaluated at 6 months, a period that provides sufficient time for the complete onset of cyclosporine’s mechanism of action, are mean change from baseline in tear breakup time (TBUT) and ocular surface disease index (OSDI) scores. SAHARA’s two primary endpoint outcome measurements of TBUT (sign) and OSDI (symptom) are established ways in which clinicians assess dry eye disease. Following the 6-month read-out, all Restasis patients will be crossed over to the TearCare group and receive a TearCare procedure. All 310 patients will be followed for an additional 18 months to assess durability of TearCare treatment and re-treatment effect over a total clinical trial period of 2 years.
“We’d like to thank our clinical investigators, their site staffs, and all study subjects for their participation in our pivotal “drug vs device” dry eye trial,” Paul Badawi, Co-Founder and CEO of Sight Sciences, said in the news release. “We embarked on SAHARA, the largest randomized controlled trial with the longest follow-up analysis of any dry eye disease RCT, with patients and payors in mind. We’ve remained steadfast in our commitment to delivering best-in-category clinical outcomes and seeking comprehensive coverage and reimbursed access to TearCare for patients whose eye care practitioners believe it is a medically necessary and reasonable treatment option to address their MGD. Having consulted from the very beginning with national and regional payors to get their input on the type of trial design that would support coverage and payment for TearCare, we arrived at SAHARA. We look forward to the important results of this pivotal “drug vs device” RCT for patients suffering from chronic dry eye disease.”
Additional information on the SAHARA trial can be found at www.clinicaltrials.gov.