NCT05062330

The TRANQUILITY 2 Trial: A Phase 3 Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease

The TRANQUILITY 2 Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 3 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: 361 (actual)
• Sponsor: Aldeyra Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The TRANQUILITY 2 Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.25%) administered 7 times over two consecutive days
DRUG	Vehicle Ophthalmic Solution	Vehicle Ophthalmic Solution administered 7 times over two consecutive days

Timeline

• Start date: 2021-08-28
• Primary completion: 2022-03-04
• Completion: 2022-03-04
• First posted: 2021-09-30
• Last updated: 2025-03-18
• Results posted: 2025-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study