Study of Safety of RVL-1201 in Treatment of Blepharoptosis
- Conditions
- Blepharoptosis
- Interventions
- Other: Vehicle ophthalmic solution
- Registration Number
- NCT03536949
- Lead Sponsor
- RVL Pharmaceuticals, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 234
- 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.
- 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 RVL-1201 Ophthalmic Solution, 0.1% RVL-1201 RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1% Vehicle ophthalmic solution Vehicle ophthalmic solution Vehicle placebo ophthalmic solution
- Primary Outcome Measures
Name Time Method Mean Change From Baseline in Intraocular Pressure (IOP) at Day 84 Screening/Day 1 to Day 84 Intraocular pressure will be measured in mmHg utilizing a tonometer and using the standard of care. If possible, the same calibrated instrument should be used for a given subject throughout the study.
Mean Change From Baseline in Pupil Diameter (PD) at Day 84 Screening/Day 1 to Day 84 Pupil diameter will be measured in millimeters (either horizontally or vertically if top of pupil is not visible in photograph) from the external photograph.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (34)
Eye Research Foundation
🇺🇸Newport Beach, California, United States
Danbury Eye Physicians and Surgeons
🇺🇸Danbury, Connecticut, United States
Sarasota Retina Institute
🇺🇸Sarasota, Florida, United States
Barnet, Dulany Perkins
🇺🇸Phoenix, Arizona, United States
Nashville Vision Associates
🇺🇸Nashville, Tennessee, United States
Maitland Vision Center
🇺🇸Maitland, Florida, United States
Mississippi Eye Associates
🇺🇸Ocean Springs, Mississippi, United States
Abrams Eye Center
🇺🇸Cleveland, Ohio, United States
R & R Research
🇺🇸San Antonio, Texas, United States
Apex Eye
🇺🇸Cincinnati, Ohio, United States
Lake Travis Eye and Laser Center
🇺🇸Lakeway, Texas, United States
Pendelton Eye Center
🇺🇸Oceanside, California, United States
North Valley Eye Medical
🇺🇸Mission Hills, California, United States
Orange County Ophthalmology Medical Group
🇺🇸Garden Grove, California, United States
North Bay Eye Associates
🇺🇸Petaluma, California, United States
East Florida Eye Institute
🇺🇸Stuart, Florida, United States
Michael K. Tran, MD Inc.
🇺🇸Westminster, California, United States
Hernando Eye Institute
🇺🇸Brooksville, Florida, United States
West Coast Eye Institute
🇺🇸Lecanto, Florida, United States
Shettle Eye Research
🇺🇸Largo, Florida, United States
Sabal Eye Care
🇺🇸Longwood, Florida, United States
Heart of America Eye Care
🇺🇸Shawnee Mission, Kansas, United States
Coastal Research Associates
🇺🇸Roswell, Georgia, United States
Kennar Eye Care
🇺🇸Pittsburg, Kansas, United States
Seidenberg Protzko Eye Associates
🇺🇸Havre De Grace, Maryland, 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
Cornerstone Eye Care
🇺🇸High Point, North Carolina, United States
Comprehensive Eye Care
🇺🇸Washington, Missouri, United States
Drs. Quinn, Foster & Associates
🇺🇸Athens, Ohio, United States
Round Rock Eye Consultants
🇺🇸Austin, Texas, United States
Texan Eye / Keystone Research, Ltd.
🇺🇸Austin, Texas, United States
Silverstein Eye Centers
🇺🇸Kansas City, Missouri, United States