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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
234
RVL-1201 ophthalmic solution, 0.1%
Vehicle placebo ophthalmic solution
Mean Change From Baseline in Intraocular Pressure (IOP) at 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.
Time frame: Screening/Day 1 to Day 84
Mean Change From Baseline in Pupil Diameter (PD) at 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.
Time frame: Screening/Day 1 to Day 84
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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
...and 25 more locations