A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions (0.25% and 0.5%) Compared to Vehicle in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic Conjunctivitis

Aldeyra Therapeutics, Inc.7 sites in 1 country318 target enrollmentMarch 30, 2018

ConditionsAllergic Conjunctivitis

InterventionsReproxalap Ophthalmic Solution (0.25%)Reproxalap Ophthalmic Solution (0.5%)Vehicle Ophthalmic Solution

DrugsReproxalap Ophthalmic Solution (0.25%)Reproxalap Ophthalmic Solution (0.5%)Vehicle Ophthalmic Solution

Overview

Phase: Phase 3
Intervention: Reproxalap Ophthalmic Solution (0.25%)
Conditions: Allergic Conjunctivitis
Sponsor: Aldeyra Therapeutics, Inc.
Enrollment: 318
Locations: 7
Primary Endpoint: Subject-reported Ocular Itching Score
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 30, 2018

End Date

November 5, 2018

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Aldeyra Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Reproxalap Ophthalmic Solution (0.25%)

Intervention: Reproxalap Ophthalmic Solution (0.25%)

Reproxalap Ophthalmic Solution (0.5%)

Intervention: Reproxalap Ophthalmic Solution (0.5%)

Vehicle Ophthalmic Solution

Intervention: Vehicle Ophthalmic Solution

Outcomes

Primary Outcomes

Subject-reported Ocular Itching Score

Time Frame: 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 Outcomes

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.)