Study of Safety and Efficacy of RVL-1201 in the Treatment of Blepharoptosis
- Conditions
- Blepharoptosis
- Interventions
- Other: Vehicle ophthalmic solution
- Registration Number
- NCT03565887
- Lead Sponsor
- RVL Pharmaceuticals, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 164
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle ophthalmic solution Vehicle ophthalmic solution Vehicle placebo ophthalmic solution RVL-1201 ophthalmic solution 0.1% RVL-1201 RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1%
- Primary Outcome Measures
Name Time Method Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group Mean change from Baseline (Day 1, Hour 0) compared with Day 1, (Hour 6), and Day 14 (Hour 2) 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).
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye Baseline Day 1 (Hour 0) and Day 1, Day 14, and Day 42 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.
Trial Locations
- Locations (35)
Hernando Eye Institute
🇺🇸Brooksville, Florida, United States
Heart of America Eye
🇺🇸Shawnee Mission, Kansas, United States
Kennar Eye Care
🇺🇸Pittsburg, Kansas, United States
Michael Tran
🇺🇸Westminster, California, United States
Danbury Eye Physicians
🇺🇸Danbury, Connecticut, United States
Nashville vision Associates
🇺🇸Nashville, Tennessee, United States
Barnet, Dulany Perkins
🇺🇸Phoenix, Arizona, United States
Orange County Ophthalmology
🇺🇸Garden Grove, California, United States
North Valley Eye
🇺🇸Mission Hills, California, United States
Pendelton Eye Center
🇺🇸Oceanside, California, United States
North Bay Eye Associates
🇺🇸Petaluma, California, United States
Eye Research Foundation
🇺🇸Newport Beach, California, United States
Shettle Eye Research
🇺🇸Largo, Florida, United States
Sabal Eye Care
🇺🇸Longwood, Florida, United States
East Florida Eye
🇺🇸Stuart, Florida, United States
Maitland Vision Center
🇺🇸Maitland, Florida, United States
Coastal Research Associates
🇺🇸Roswell, Georgia, United States
Sarasota Retina Institute
🇺🇸Sarasota, Florida, United States
Seidenberg Protzko Eye
🇺🇸Havre De Grace, Maryland, United States
Mississippi Eye
🇺🇸Ocean Springs, Mississippi, United States
Rochester Ophthalmological
🇺🇸Rochester, New York, United States
Comprehensive Eye Care
🇺🇸Washington, Missouri, United States
South Shore Eye
🇺🇸Wantagh, New York, United States
Cornerstone Eye
🇺🇸High Point, North Carolina, United States
CEENTA
🇺🇸Charlotte, North Carolina, United States
Apex Eye
🇺🇸Cincinnati, Ohio, United States
Quinn, Foster & Assoc.
🇺🇸Athens, Ohio, United States
Abrams Eye Center
🇺🇸Cleveland, Ohio, United States
R&R Research
🇺🇸San Antonio, Texas, United States
Medical Center Ophthalmology Assocs - Keystone Research
🇺🇸San Antonio, Texas, United States
Lake Travis Eye
🇺🇸Lakeway, Texas, United States
Silverstein Eye
🇺🇸Kansas City, Missouri, United States
Round Rock Eye
🇺🇸Austin, Texas, United States
Texan Eye / Keystone
🇺🇸Austin, Texas, United States
West Coast Eye
🇺🇸Lecanto, Florida, United States