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 Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 421 (actual)
• Sponsor: Aldeyra Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-04-29
• Primary completion: 2024-11-03
• Completion: 2024-11-03
• First posted: 2024-05-22
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study