A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions in Subjects with Acute Allergic Conjunctivitis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
318
Reproxalap Ophthalmic Solution (0.25%) administered once.
Reproxalap Ophthalmic Solution (0.5%) administered once.
Vehicle Ophthalmic Solution administered once.
Cornea Consultants of Arizon
Phoenix, Arizona, United States
Eye Site Sacramento
Sacramento, California, United States
East West Eye Institute
Torrance, California, United States
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, United States
Subject-reported Ocular Itching Score
Subject-reported ocular itching score area under the curve from 10 to 60 minutes post allergen challenge using a 0 to 4 scale (0 = none, 4 = severe) was assessed. The least squares mean was derived from analysis of covariance of area under the curve with baseline as a covariate and treatment as a fixed effect The possible range for area under the curve least squares mean is 0 to 100, where a lower score is better.
Time frame: Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.
Number of Subjects With Two-point Reduction in Itching Score
The number of within subject 2-point responders (2-point reduction in itch score from 20-60 minutes post-challenge) using a 0 to 4 scale (0 = least, 4 = most) from the 5-minute post-challenge itch score at baseline was assessed.
Time frame: Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.
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Andover Eye Associates
Andover, Massachusetts, United States
Eye Clinics of South Texas
San Antonio, Texas, United States
R & R Research, LLC
San Antonio, Texas, United States