CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 235 enrolled
Drug / intervention
TearCare +1 moredevice
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/NCT03857919
NCT03857919N/ACompleted
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Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the TearCare® System in the Treatment of the Signs and Symptoms of Dry Eye Disease

Sight Sciences, Inc.·interventional·Posted Feb 28, 2019·Updated Oct 1, 2025

In Brief

A clinical study evaluating TearCare and LipiFlow for Dry Eye and Meibomian Gland Dysfunction. Completed, enrolled 235 participants across 10 sites.

Detailed Summary

In this study, the TearCare System will be compared with the LipiFlow Thermal Pulsation System in patients with dry eye disease. The objective is to demonstrate that the TearCare System is safe and effective in relieving the signs and symptoms of dry eye disease.

Study Details

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

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 28, 2019
Enrollment StartMar 3, 2019
Primary CompletionFeb 17, 2020
Study CompletionDec 18, 2020
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.3 years ago

Interventions

TearCaredevice

The TearCare SmartLids will be applied to the external surface of each eyelid. The TearCare System will be turned on and heat will be delivered to the eyelids for 15 minutes. Immediately following the thermal portion of the procedure, the SmartLids will be removed and the doctor will manually express the meibomian glands.

LipiFlowdevice

The LipiFlow activators will be placed between the inner eyelid and the corneal surface of each eye. The LipiFlow System will be turned on and heat and pressure will be delivered to each eyelid for 12 minutes.