NCT03916042

A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial of Reproxalap to Assess the Safety and Efficacy in Subjects With Dry Eye Disease

A Multi-Center, Phase 2, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% Novel Formulation) Compared to Vehicle in Subjects With Dry Eye Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Aldeyra Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Multi-Center, Phase 2, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% Novel Formulation) Compared to Vehicle in Subjects with Dry Eye Disease

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	Reproxalap Ophthalmic Solution (0.25% Novel Formulation) QID to BID	Reproxalap Opthalmic Solution (0.25% Novel Formulation) administered QID for four weeks, followed by BID administration for eight weeks
DRUG	Vehicle Ophthalmic Solution (0.25% Novel Formulation) QID to BID	Vehicle Ophthalmic Solution administered QID for four weeks, followed by BID administration for eight weeks

Timeline

• Start date: 2019-04-23
• Primary completion: 2019-11-22
• Completion: 2019-11-22
• First posted: 2019-04-16
• Last updated: 2025-03-03
• Results posted: 2025-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study