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 | Biotech Hunter

Enrollment

757

Participants

Timeline

Start Date

January 26, 2021

Primary Completion Date

October 11, 2022

Study Completion Date

October 11, 2022

Conditions

Dry Eye Disease

Interventions

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).

Trial Locations (1)

Andover Eye Associates, Andover