drugset / Trial / NCT02436759

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

NCT02436759 ↗

Phase 3 Completed 140 enrolled RVL Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase 3 study is to evaluate the safety and efficacy of RVL-1201 Ophthalmic Solution in the treatment of acquired blepharoptosis (ptosis) and to assess the safety and comfort of RVL-1201 Ophthalmic Solution for an extended dosing period of 6 weeks.

Timeline

Start
2015-05
Primary completion
2016-11
Completion
2016-11

Outcome

Met primary endpoint

registry analysis (superiority test); RVL-1201 vs Vehicle Ophthalmic Solution; p <0.0001; ANCOVA NCT02436759 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject RVL-1201 Unknown 0.1 % Topical

Indications