CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 345 enrolled
Drug / intervention
Cyclosporine Ophthalmic 0.05% Ophthalmic Emulsion +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04795752
NCT04795752N/ACompleted
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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)

Sight Sciences, Inc.·interventional·Posted Mar 12, 2021·Updated Nov 24, 2025

In Brief

A clinical study evaluating TearCare System and Cyclosporine Ophthalmic 0.05% Ophthalmic Emulsion for Dry Eye and Meibomian Gland Dysfunction. Completed, enrolled 345 participants across 14 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye, Meibomian Gland Dysfunction
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 12, 2021
Enrollment StartApr 28, 2021
Primary CompletionSep 23, 2024
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 5.3 years ago

Interventions

TearCare Systemdevice

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.

Cyclosporine Ophthalmic 0.05% Ophthalmic Emulsiondrug

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.