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

NCT03565887 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2020-09-16

Study results available
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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.

Conditions

  • Blepharoptosis

Interventions

DRUG

RVL-1201

RVL-1201 ophthalmic solution 0.1%

OTHER

Vehicle ophthalmic solution

Vehicle placebo ophthalmic solution

Sponsors & Collaborators

  • RVL Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-28
Primary Completion
2019-04-11
Completion
2019-04-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03565887 on ClinicalTrials.gov