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 | Biotech Hunter

Enrollment

422

Participants

Timeline

Start Date

April 16, 2019

Primary Completion Date

October 4, 2019

Study Completion Date

October 4, 2019

Conditions

Dry Eye

Interventions

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

Trial Locations (1)

Eye Research Foundation, Newport Beach