Sight Sciences completes enrollment in trial of TearCare system
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Sight Sciences has completed enrollment in the SAHARA trial, which is evaluating the TearCare system to treat the signs and symptoms of dry eye disease, according to a press release.
The multicenter, randomized controlled trial includes 310 participants and will compare the dry eye therapeutic device against 6 months of twice-daily Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan). Those in the TearCare group received an in-office eyelid debridement, a 15-minute thermal session with TearCare and physician-guided manual expression of the meibomian glands.
The primary endpoints of the trial are changes from baseline in tear breakup time and Ocular Surface Disease Index score. Trial results are expected in the second quarter of 2023, and participants will be followed for an additional 18 months to assess durability of the treatment and re-treatment effect for a total of 2 years.
“We embarked on SAHARA, the largest randomized controlled trial with the longest follow-up analysis of any dry eye disease [randomized controlled trial], with patients and payers in mind,” Paul Badawi, co-founder and CEO of Sight Sciences, said in the release. “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 [meibomian gland dysfunction].”
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