Phase 1/2a, multicenter, randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group study conducted in adult subjects with acquired blepharoptosis.
This is a Phase 1/2a, multicenter, randomized, vehicle-controlled, double-masked, single-dose, parallel-group study conducted in adult subjects with acquired blepharoptosis. Subjects will receive a one-time application of randomized, double-masked IP. Approximately 30 subjects will be enrolled in this study. Eligible subjects will be randomized to 1 of the following 3 treatment groups in a 1:1:1 ratio and will receive a single dose of double-masked IP externally on the upper eyelid of both eyes (OU):
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
33
Oxymetazoline ophthalmic gel
Oxymetazoline ophthalmic gel
Vehicle ophthalmic gel
Eye Research Foundation
Newport Beach, California, United States
Steve Yoelin Medical Associates
Newport Beach, California, United States
Brian Biesman, M.D
Nashville, Tennessee, United States
Percentage of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability])
Adverse events
Time frame: Day 2-5
Upper Eyelid Height
Percentage of subjects with increase in Margin reflex distance 1 (MRD1) of 1 mm at Hours 2 and 6 on Day 1
Time frame: Day 1
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