A Clinical Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease

NCT06424444 | Completed Phase 3 FDA Drug

• 1 other identifier: ADX-102-DED-031
• Study Type: interventional
• Target: 421
• Locations: 1 country
• Sites: 1

Brief Summary

A Multicenter, Phase 3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Environment Exposure Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• Subject-reported ocular discomfort score over Week 1 to Week 6

  Measured using a 0 - 100 visual analog scale where 0 is "no discomfort" and 100 is "maximal discomfort"

  From Day -14 to Day 43

Study Arms (2)

Reproxalap Ophthalmic Solution (0.25%)

EXPERIMENTAL

Drug: Reproxalap ophthalmic solution (0.25%)

Vehicle Ophthalmic Solution

PLACEBO COMPARATOR

Drug: Vehicle ophthalmic solution

Interventions

Reproxalap ophthalmic solution (0.25%) DRUG

Reproxalap ophthalmic solution (0.25%) administered QID for four weeks, followed by BID administration for two weeks

Reproxalap Ophthalmic Solution (0.25%)

Vehicle ophthalmic solution DRUG

Vehicle ophthalmic solution administered QID for four weeks, followed by BID administration for two weeks

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:

• at least 18 years of age;
• written informed consent and sign the Health Information Portability and Accountability Act (HIPAA) form;
• history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1

You may not qualify if:

• ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1;
• contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the trial;
• eye drops within 2 hours of Visit 1;
• laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
• topical ocular cyclosporine, lifitegrast, corticosteroid, or any other topical ocular prescription medication within 90 days of Visit 1

Sponsors & Collaborators

• Aldeyra Therapeutics, Inc.: lead

Study Sites (1)

Core, Inc.

Shelby, North Carolina, 28150, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

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: May 17, 2024
• First Posted: May 22, 2024
• Study Start: April 29, 2024
• Primary Completion: November 3, 2024
• Study Completion: November 3, 2024
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)