drugset / Trial / NCT02436759
Study of the Safety and Efficacy of RVL-1201 in the Treatment of Acquired Blepharoptosis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RVL-1201 | Unknown | 0.1 % | Topical |