A Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of RVL-1201 in the Treatment of Acquired Blepharoptosis

RVL Pharmaceuticals, Inc.35 sites in 1 country164 target enrollmentJune 28, 2018

ConditionsBlepharoptosis

InterventionsRVL-1201 Vehicle ophthalmic solution

DrugsRVL-1201

Overview

Phase: Phase 3
Intervention: RVL-1201
Conditions: Blepharoptosis
Sponsor: RVL Pharmaceuticals, Inc.
Enrollment: 164
Locations: 35
Primary Endpoint: Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 28, 2018

End Date

April 22, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

RVL Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or Female 9 years of age or older
•Females must not be pregnant or planning to get pregnant and must use acceptable form of contraception
•Must be able to self-administer study medication
•Must be able to understand and sign an informed consent form. For minor subjects, the subject's parent or legal guardian must provide permission by signing an ICF on behalf of the subject and the subject should provide assent.