NCT04795752

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

Prospective, Randomized, Masked, Controlled Trial To Evaluate The Safety And Effectiveness Of The TearCare® System In The Treatment Of The Signs And Symptoms Of Dry Eye Disease (SAHARA)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 345 (actual)
• Sponsor: Sight Sciences, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the safety and effectiveness of TearCare® procedures compared to Restasis® to treat the signs and symptoms of dry eye disease in adult patients.

Detailed description

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).

Conditions

• Dry Eye
• Meibomian Gland Dysfunction

Interventions

Type	Name	Description
DEVICE	TearCare System	TearCare procedures in this study will include an in-office eyelid debridement, 15 minute bilateral thermal session with the TearCare System, immediately followed by manual expression of the meibomian glands using the Clearance Assistant Plus device. Subjects randomized to TearCare will receive one in-office TearCare procedure within 7 days of the Baseline visit and at 5 Months.
DRUG	Cyclosporine Ophthalmic 0.05% Ophthalmic Emulsion	Restasis group will be required to self-administer 1 drop twice a day from baseline through the Month 6 visit. At the Month 6 visit subjects will stop Restasis and receive a single TearCare treatment.

Timeline

• Start date: 2021-04-28
• Primary completion: 2024-09-23
• Completion: 2024-09-23
• First posted: 2021-03-12
• Last updated: 2025-11-24
• Results posted: 2025-11-24

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated device study