CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 252 enrolled
Drug / intervention
Brimonidine Tartrate +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/NCT03785340
NCT03785340Phase 3Completed
CompareCT.gov

A Phase 3 Randomized, Placebo-Controlled, Double-Masked, Multicenter, Safety and Efficacy Study of Brimonidine Tartrate 0.2% Nanoemulsion Eye Drops in Patients With Dry Eye Disease (DED)

Ocugen·interventional·Posted Dec 24, 2018·Updated Jul 18, 2022

In Brief

A Phase 3 clinical trial evaluating Brimonidine Tartrate and Placebos for Dry Eye. Completed, enrolled 252 participants across 16 sites.

Detailed Summary

This study evaluates the use of Brimonidine tartrate nanoemulsion eye drop solution in the treatment of Dry Eye Disease (DED). Half of participants will receive Brimonidine and half will receive ophthalmic buffered saline (placebo).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedDec 24, 2018
Enrollment StartDec 3, 2018
Primary CompletionFeb 25, 2019
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.5 years ago

Interventions

Brimonidine Tartratedrug

Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks.

Placebosdrug

Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks.