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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Blepharoptosis

Intervention / Treatment
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* Drug: RVL-1201
* Other: Vehicle ophthalmic solution


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: Congenital ptosis Horner syndrome Myasthenia gravis Mechanical ptosis Previous ptosis surgery Resting heart rate outside the normal range Hypertension with resting diastolic blood pressure Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RVL-1201 ophthalmic solution 0.1%<br>RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1% | Drug: RVL-1201<br>* RVL-1201 ophthalmic solution 0.1%<br>|
| Placebo Comparator: Vehicle ophthalmic solution<br>Vehicle placebo ophthalmic solution | Other: Vehicle ophthalmic solution<br>* Vehicle placebo ophthalmic solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group | LPFT Total Score is the number of points seen in the top 4 rows on the LPFT. Possible scores range from 0 (no points seen) to 35 (all points seen). | Mean change from Baseline (Day 1, Hour 0) compared with Day 1, (Hour 6), and Day 14 (Hour 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye | The Marginal Reflex Distance (MRD) is the distance from the center pupillary light reflex to the central margin of the upper eyelid. The MRD is measured from an external photograph using a handheld caliper and a millimeter ruler label placed on the subject's forehead as a measurement legend. | Baseline Day 1 (Hour 0) and Day 1, Day 14, and Day 42 |