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

NCT06424444 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 421

Last updated 2025-10-01

No results posted yet for this study

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

Interventions

DRUG

Reproxalap ophthalmic solution (0.25%)

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

DRUG

Vehicle ophthalmic solution

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

Sponsors & Collaborators

  • Aldeyra Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-29
Primary Completion
2024-11-03
Completion
2024-11-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06424444 on ClinicalTrials.gov