ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis

Phase 3

Completed

Interventions: Drug: Reproxalap Ophthalmic Solution (0.25%)
Drug: Vehicle Ophthalmic Solution
Drug: Reproxalap Ophthalmic Solution (0.5%)

Brief Summary: 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

Recruitment & Eligibility

Inclusion Criteria

be at least 18 years of age of either gender and any race
have a positive history of ocular allergies and a positive skin test reaction to a seasonal allergen (grasses, ragweed, and/or trees) as confirmed by an allergic skin test at the Screening Visit or within the past 24 months;
have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart

Exclusion Criteria

have known contraindications or sensitivities to the use of the investigational product or any of its components
have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or a diagnosis of dry eye)
have had ocular surgical intervention within three (3) months prior to Visit 1 or during the trial and/or a history of refractive surgery six (6) months prior to Visit 1 or have ocular or systemic surgery planned during the study or within 30 days after
have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
have the presence of an active ocular infection (bacterial, viral or fungal) or positive history of an ocular herpetic infection at any visit
be a female who is currently pregnant, planning a pregnancy, lactating, not using a medically acceptable form of birth control throughout the trial duration, or has a positive urine pregnancy test at Visit 1

Arm && Interventions

Group	Intervention	Description
Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.25%)	-
Vehicle Ophthalmic Solution	Vehicle Ophthalmic Solution	-
Reproxalap Ophthalmic Solution (0.5%)	Reproxalap Ophthalmic Solution (0.5%)	-

Primary Outcome Measures

Name	Time	Method
Subject-reported Ocular Itching Score	Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.	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.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Two-point Reduction in Itching Score	Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.	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.

Locations (7): Eye Clinics of South Texas
🇺🇸
San Antonio, Texas, United States
R & R Research, LLC
🇺🇸
San Antonio, Texas, United States
Andover Eye Associates
🇺🇸
Andover, Massachusetts, United States
Cornea Consultants of Arizon
🇺🇸
Phoenix, Arizona, United States
Seidenberg Protzko Eye Associates
🇺🇸
Havre De Grace, Maryland, United States
East West Eye Institute
🇺🇸
Torrance, California, United States
Eye Site Sacramento
🇺🇸
Sacramento, California, United States