NCT03404115

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

A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects With Dry Eye Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Aldeyra Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects with Dry Eye Disease

Conditions

• Dry Eye Syndrome

Interventions

Type	Name	Description
DRUG	Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks.
DRUG	Reproxalap Ophthalmic Solution (0.1%)	Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks.
DRUG	Vehicle Ophthalmic Solution	Vehicle Ophthalmic Solution administered for approximately twelve weeks.

Timeline

• Start date: 2018-01-02
• Primary completion: 2018-07-11
• Completion: 2018-07-11
• First posted: 2018-01-19
• Last updated: 2025-02-06
• Results posted: 2025-02-06

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study