NCT03494504

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

Completed Phase 3 Results posted Last updated 11 February 2025

What this trial tests

Phase 3 trial testing Reproxalap Ophthalmic Solution (0.25%) in Allergic Conjunctivitis in 318 participants. Completed in 5 November 2018.

Timeline

30 March 2018

Primary endpoint
5 November 2018

5 November 2018

Quick facts

Lead sponsor	Aldeyra Therapeutics, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	318
Start date	30 March 2018
Primary completion	5 November 2018
Estimated completion	5 November 2018
Sites	7 locations across United States

Drugs / interventions tested

• Reproxalap Ophthalmic Solution (0.25%) — full drug profile →
• Reproxalap Ophthalmic Solution (0.5%) — full drug profile →
• Vehicle Ophthalmic Solution — full drug profile →

Conditions studied

• Allergic Conjunctivitis — all drugs for Allergic Conjunctivitis →

Sponsor

Aldeyra Therapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with Allergic Conjunctivitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Subject-reported Ocular Itching Score Primary · 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.

Group	Value	95% CI
Reproxalap Ophthalmic Solution (0.25%)	52.003	± 3.3053
Reproxalap Ophthalmic Solution (0.5%)	60.040	± 3.4552
Vehicle Ophthalmic Solution	74.657	± 3.3076

Number of Subjects With Two-point Reduction in Itching Score Secondary · 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.

Group	Value	95% CI
Reproxalap Ophthalmic Solution (0.25%)	88
Reproxalap Ophthalmic Solution (0.5%)	77
Vehicle Ophthalmic Solution	77

Adverse events — posted to ClinicalTrials.gov

Time frame: The period of time over which adverse events were collected for each subject in the clinical trial was approximately two months.. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Reproxalap Ophthalmic Solution (0.25%)

Serious: 0/109 (0%)

Deaths: 0/109

Reproxalap Ophthalmic Solution (0.5%)

Serious: 0/100 (0%)

Deaths: 0/100

Vehicle Ophthalmic Solution

Serious: 0/109 (0%)

Deaths: 0/109

Other adverse events (1 terms — click to expand)

Reaction	System	Reproxalap Ophthalmic Solu…	Reproxalap Ophthalmic Solu…	Vehicle Ophthalmic Solution
General disorders and administration site conditions	General disorders	—	—	—

Data from ClinicalTrials.gov NCT03494504 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.