Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment
Part of paid clinical trials in Newport Beach, California.
- Sponsor
- BRIM Biotechnology Inc.
- Study ID
- NCT04343287
- Phase
- PHASE2/PHASE3
- Status
- Completed
Conditions
- Dry Eye Syndrome
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- BRM421 — DRUGThe active control with BRM421 solution
- Placebo — DRUGThe vehicle solution
Study Details
The objective of this study is to compare the safety and efficacy of BRM421 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.
Key Dates
- Start date
- Jan 15, 2020
- Status verified
- Sep 2021
- Primary completion
- Jun 23, 2020
- Completion
- Jun 23, 2020
Study Design
- Enrollment
- 220 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: BRM421 Ophthalmic SolutionA topical solution of BRIM421 ophthalmic drops
- Placebo Comparator: PlaceboA vehicle ophthalmic drops
Primary Outcome Measure
Ocular Sign: Change From Baseline in Total Corneal Staining Score to Day 14 [ Time Frame: change from baseline to 2 weeks ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Eye Research Foundation | Newport Beach | California | 92663 | - |
| Midwest Cornea Associates, LLC | Indianapolis | Indiana | 46290 | - |
| Andover Eye Associates | Andover | Massachusetts | 01810 | - |
| Total Eye Care | Memphis | Tennessee | 38119 | - |