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



Status:Recruiting
Healthy:No
Age Range:9 - Any
Updated:2/14/2019
Start Date:June 28, 2018
End Date:February 28, 2019
Contact:Roselyn Judd
Email:rjudd@pointguardllc.com
Phone:586-212-0237

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

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.


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
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Petaluma, California 94954
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