Study of Safety of RVL-1201 in Treatment of Blepharoptosis
Completed · Phase 3 · Has a placebo group
Conditions studied: Blepharoptosis
In brief
Phase 3 study to evaluate the extended safety of RVL-1201 compared to placebo for treatment of blepharoptosis. Eligible subjects will be randomized to one of 2 treatment arms.
Key facts
- Study ID
- NCT03536949
- Run by
- RVL Pharmaceuticals, Inc.
- People needed
- 234
- Starts
- 2018-06-20
- Expected to finish
- 2019-03-27
- 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 (ICF). 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 Medical Group — Garden Grove, California, United States
- North Valley Eye Medical — 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 K. Tran, MD Inc. — Westminster, California, United States
- Danbury Eye Physicians and Surgeons — Danbury, Connecticut, United States
- Hernando Eye Institute — Brooksville, Florida, United States
- Shettle Eye Research — Largo, Florida, United States
- West Coast Eye Institute — 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 Institute — Stuart, Florida, United States
- Coastal Research Associates — Roswell, Georgia, United States
- Kennar Eye Care — Pittsburg, Kansas, United States
- Heart of America Eye Care — Shawnee Mission, Kansas, United States
- Seidenberg Protzko Eye Associates — Havre de Grace, Maryland, United States
- Mississippi Eye Associates — Ocean Springs, Mississippi, United States
- Silverstein Eye Centers — Kansas City, Missouri, United States
- Comprehensive Eye Care — Washington, Missouri, United States
- Rochester Ophthalmological Group — Rochester, New York, United States
- South Shore Eye Care — Wantagh, New York, United States
- CEENTA — Charlotte, North Carolina, United States
Full record on ClinicalTrials.gov
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