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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
164
RVL-1201 ophthalmic solution 0.1%
Vehicle placebo ophthalmic solution
Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group
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).
Time frame: Mean change from Baseline (Day 1, Hour 0) compared with Day 1, (Hour 6), and Day 14 (Hour 2)
Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye
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.
Time frame: Baseline Day 1 (Hour 0) and Day 1, Day 14, and Day 42
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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
...and 26 more locations