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

NCT04795752 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 345

Last updated 2025-11-24

Study results available
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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.

Conditions

  • Dry Eye
  • Meibomian Gland Dysfunction

Interventions

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.

Sponsors & Collaborators

  • Sight Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Jaime Dickerson, PhD · Sight Sciences, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-28
Primary Completion
2024-09-23
Completion
2024-09-23
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04795752 on ClinicalTrials.gov