drugset / Trial / NCT03785340

Study of Brimonidine Tartrate Nanoemulsion Eye Drop Solution in the Treatment of Dry Eye Disease (DED)

NCT03785340 ↗

Phase 3 Completed 252 enrolled Ocugen
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2018-12-03
Primary completion
2019-02-25
Completion
2019-02-25

Outcome

Missed primary endpoint

registry analysis (superiority test); OCU-310 vs Placebo; p = 0.739; Least squares mean difference -0.844 (95% CI -5.823 to 4.134) NCT03785340 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Brimonidine Unknown 0.2 % Other

Indications