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

• Status: Completed
• Trial end date: 2019-04-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RevitaLid Inc.; RVL Pharmaceuticals, Inc.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. Male or Female 9 years of age or older

2. Females must not be pregnant or planning to get pregnant and must use acceptable form of contraception

3. Must be able to self-administer study medication

4. 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.

Exclusion Criteria:

1. Congenital ptosis

2. Horner syndrome

3. Myasthenia gravis

4. Mechanical ptosis

5. Previous ptosis surgery

6. Resting heart rate outside the normal range

7. Hypertension with resting diastolic blood pressure

8. Pregnancy or lactation