NCT06389214

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

A Randomized, Double-Masked, Vehicle-Controlled Parallel Group 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 3
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Aldeyra Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Dry eye chamber challenge trial.

Conditions

• Dry Eye Disease

Interventions

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

Timeline

• Start date: 2024-04-09
• Primary completion: 2024-06-11
• Completion: 2024-06-11
• First posted: 2024-04-29
• Last updated: 2025-06-05

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study