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

NCT03494504 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ADX-102-AC-008
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 7

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

Conditions

Allergic Conjunctivitis

Keywords

reproxalap

Outcome Measures

Primary Outcomes (1)

• 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.

  Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.

Secondary Outcomes (1)

• 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.

Study Arms (3)

Reproxalap Ophthalmic Solution (0.25%)

EXPERIMENTAL

Drug: Reproxalap Ophthalmic Solution (0.25%)

Reproxalap Ophthalmic Solution (0.5%)

EXPERIMENTAL

Drug: Reproxalap Ophthalmic Solution (0.5%)

Vehicle Ophthalmic Solution

PLACEBO COMPARATOR

Drug: Vehicle Ophthalmic Solution

Interventions

Reproxalap Ophthalmic Solution (0.25%) DRUG

Reproxalap Ophthalmic Solution (0.25%) administered once.

Reproxalap Ophthalmic Solution (0.25%)

Reproxalap Ophthalmic Solution (0.5%) DRUG

Reproxalap Ophthalmic Solution (0.5%) administered once.

Reproxalap Ophthalmic Solution (0.5%)

Vehicle Ophthalmic Solution DRUG

Vehicle Ophthalmic Solution administered once.

Vehicle Ophthalmic Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aldeyra Therapeutics, Inc.: lead

Study Sites (7)

Cornea Consultants of Arizon

Phoenix, Arizona, 85032, United States

Location

Eye Site Sacramento

Sacramento, California, 95819, United States

Location

East West Eye Institute

Torrance, California, 90505, United States

Location

Seidenberg Protzko Eye Associates

Havre de Grace, Maryland, 21078, United States

Location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Eye Clinics of South Texas

San Antonio, Texas, 78209, United States

Location

R & R Research, LLC

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Sr. Director, Clinical Operations
• Organization: Aldeyra Therapeutics, Inc.

bcavanagh@aldeyra.com

781-257-3063

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 11, 2018
• Study Start: March 30, 2018
• Primary Completion: November 5, 2018
• Study Completion: November 5, 2018
• Last Updated: February 11, 2025
• Results First Posted: February 11, 2025

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)