Sight Sciences Announces Results in SAHARA Clinical Trial Comparing TearCare vs. Standard of Care Restasis for Dry Eye Disease
Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company recently unveiled the Phase I results of the SAHARA randomized controlled trial (RCT) at the American Academy of Optometry Annual Meeting in New Orleans, held on October 12, 2023. The SAHARA RCT compared TearCare technology, an innovative interventional eyelid procedure, with Restasis prescription eyedrops, the conventional pharmaceutical treatment for dry eye disease (DED). The primary objective of the study was to assess tear break-up time (TBUT), a key measure of aqueous retention, tear stability, and the tear film’s ability to protect the ocular surface. TearCare proved superior to Restasis at every measured time point (one week, one month, three months, and six months).
The TearCare® System is a device which combines wearable and smart technology and delivers localized heat therapy to adult patients experiencing evaporative dry eye disease caused by meibomian gland dysfunction (MGD), in conjunction with manual expression of the meibomian glands. Meibomian gland disease or MGD, which is associated with up to 86% of dry eye cases. Approximately 20 million adults in the U.S. have dry eye disease.
In the study, patients receiving TearCare treatments demonstrated statistically significant improvements in TBUT from baseline. This improvement increased from a 1.5-second enhancement at one week to a substantial 2.5-second improvement at the six-month mark. Additionally, TearCare excelled in other key objective measures, including improving the underlying health of meibomian glands. It outperformed Restasis in meibomian gland secretion scores, the number of glands yielding any liquid, and the number of glands yielding clear liquid. This comprehensive approach to DED addresses the root causes, setting it apart from traditional pharmaceutical treatments.
On top of these objective improvements, both TearCare and Restasis delivered comparable, statistically significant enhancements in patient-reported outcomes. These outcomes, measured by the Ocular Surface Disease Index (OSDI) scores, Symptoms Assessment in Dry Eye (SANDE) scores, and Eye Dryness Scores (EDS), subjectively assess the severity of dry eye symptoms.
Dr. Bloomenstein, O.D., FAAO, Director of Optometric Services at Schwartz Laser Eye Center and a Principal Investigator for the SAHARA clinical trial, expressed his excitement about the results. He stated, “Pharmaceutical intervention with Restasis has been the hallmark of dry eye treatment since its introduction. The results of the SAHARA RCT utilizing TearCare technology, which treats the root cause of dry eye disease, should make us rethink our options for the optimal treatment for dry eye.”
In Phase II of the SAHARA trial subjects from the Restasis group will transition to receive the TearCare procedure and be monitored for six additional months. Meanwhile, those in the TearCare group will continue to receive interventional eyelid procedures as necessary over an additional 18 months, providing valuable insights into the durability of the TearCare treatment. The company hopes that these randomized clinical trials will support reimbursement coverage for TearCare, as today patients are paying out of pocket for the technology.