drugset / Trial / NCT03565887

Study of Safety and Efficacy of RVL-1201 in the Treatment of Blepharoptosis

NCT03565887 ↗

Phase 3 Completed 164 enrolled RVL Pharmaceuticals, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

Phase 3 study to evaluate the safety and efficacy of treatment with RVL-1201 compared to placebo for treatment of blepharoptosis. Eligible subjects will be randomized to one of 2 treatment arms.

Timeline

Start
2018-06-28
Primary completion
2019-04-11
Completion
2019-04-22

Outcome

Met primary endpoint

registry analysis (superiority test); RVL-1201 Ophthalmic Solution 0.1% vs Vehicle Ophthalmic Solution; p <0.0001; ANCOVA; NCT03565887 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxymetazoline Other / unclassified 0.1 % Other

Indications