Skip to main content
OpenTrials
Completed

NCT Number: NCT06424444

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Core, Inc.

Shelby, North Carolina, 28150, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Reproxalap ophthalmic solution (0.25%)

Drug

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

Vehicle Ophthalmic Solution

Drug

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

Primary outcomes

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

    Time frame: From Day -14 to Day 43

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

Sponsors and collaborators

Lead sponsor

Aldeyra Therapeutics, Inc.

Industry

Registry information

Official study title

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 Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 22, 2024
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.