NCT05424549

A Clinical Trial to Evaluate the Safety and Efficacy of Rreproxalap in Adults With Dry Eye Disease

A Randomized, Double-Masked, Vehicle-Controlled Crossover Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Aldeyra Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A Randomized, Double-Masked, Vehicle-Controlled Crossover Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.25%) dosed six times over two consecutive days
DRUG	Vehicle Ophthalmic Solution	Vehicle Ophthalmic Solution dosed six times over two consecutive days

Timeline

• Start date: 2022-03-09
• Primary completion: 2022-05-09
• Completion: 2022-05-09
• First posted: 2022-06-21
• Last updated: 2025-01-15
• Results posted: 2025-01-15

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study