Study of Safety and Efficacy of RVL-1201 in the Treatment of Blepharoptosis
Completed · Phase 3 · Has a placebo group
Conditions studied: Blepharoptosis
In brief
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.
Key facts
- Study ID
- NCT03565887
- Run by
- RVL Pharmaceuticals, Inc.
- People needed
- 164
- Starts
- 2018-06-28
- Expected to finish
- 2019-04-22
- Last updated by the study team
- 2020-09-16
Who can join
Age: 9 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Barnet, Dulany Perkins — Phoenix, Arizona, United States
- Orange County Ophthalmology — Garden Grove, California, United States
- North Valley Eye — Mission Hills, California, United States
- Eye Research Foundation — Newport Beach, California, United States
- Pendelton Eye Center — Oceanside, California, United States
- North Bay Eye Associates — Petaluma, California, United States
- Michael Tran — Westminster, California, United States
- Danbury Eye Physicians — Danbury, Connecticut, United States
- Hernando Eye Institute — Brooksville, Florida, United States
- Shettle Eye Research — Largo, Florida, United States
- West Coast Eye — Lecanto, Florida, United States
- Sabal Eye Care — Longwood, Florida, United States
- Maitland Vision Center — Maitland, Florida, United States
- Sarasota Retina Institute — Sarasota, Florida, United States
- East Florida Eye — Stuart, Florida, United States
- Coastal Research Associates — Roswell, Georgia, United States
- Kennar Eye Care — Pittsburg, Kansas, United States
- Heart of America Eye — Shawnee Mission, Kansas, United States
- Seidenberg Protzko Eye — Havre de Grace, Maryland, United States
- Mississippi Eye — Ocean Springs, Mississippi, United States
- Silverstein Eye — Kansas City, Missouri, United States
- Comprehensive Eye Care — Washington, Missouri, United States
- Rochester Ophthalmological — Rochester, New York, United States
- South Shore Eye — Wantagh, New York, United States
- CEENTA — Charlotte, North Carolina, United States
Full record on ClinicalTrials.gov
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