Safety And Effectiveness Of The TearCare® System In The Treatment Of The Signs And Symptoms Of Dry Eye Disease (SAHARA)

In this prospective, multicenter, randomized, active-controlled trial, TearCare is compared to cyclosporine 0.05% ophthalmic emulsion (Restasis) in eyes with dry eye disease (DED). Subjects randomized to TearCare receive TearCare treatment at baseline and Month 5, while subjects randomized to Restasis dose twice-daily with Restasis from baseline through Month 6. Primary inference is based on outcomes at the Month 6 visit including the co-primary endpoints tear break-up time (TBUT) and Ocular Surface Disease Index (OSDI).