NCT04735393

A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease

A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of 0.25% Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 757 (actual)
• Sponsor: Aldeyra Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of 0.25% Reproxalap Ophthalmic Solution in Subjects with Dry Eye Disease

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.25%) administered for six weeks (QID for four weeks then BID for two weeks).
DRUG	Placebo Comparator	Vehicle Ophthalmic Solution administered for six weeks (QID for four weeks then BID for two weeks).
DRUG	Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.25%) administered for one year (QID for four weeks then BID for 11 months).
DRUG	Placebo Comparator	Vehicle Ophthalmic Solution administered for one year (QID for four weeks then BID for 11 months).

Timeline

• Start date: 2021-01-26
• Primary completion: 2022-10-11
• Completion: 2022-10-11
• First posted: 2021-02-03
• Last updated: 2025-11-26
• Results posted: 2025-11-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study