NCT03879863

The RENEW Trial: A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease

The RENEW Trial: A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap 0.25% Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 422 (actual)
• Sponsor: Aldeyra Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The RENEW Trial is a Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap 0.25% Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease

Conditions

• Dry Eye

Interventions

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

Timeline

• Start date: 2019-04-16
• Primary completion: 2019-10-04
• Completion: 2019-10-04
• First posted: 2019-03-19
• Last updated: 2025-01-23
• Results posted: 2025-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study