Trials / Completed
CompletedNCT05695781
Assessment of the Safety and Efficacy of BRM421 Ophthalmic Solutions in Dry Eye Subjects.
A Multi-Center, Randomized, Double Masked, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of BRM421 Ophthalmic Solution in Subjects With Dry Eye Using a Controlled Adverse Environment (CAE®) Model
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 740 (actual)
- Sponsor
- BRIM Biotechnology Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to compare the safety and efficacy of BRM421 OS to vehicle for the treatment of the signs and symptoms of dry eye disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BRM421 Ophthalmic Solution | A topical drop of BRM421 ophthalmic solution. |
| DRUG | Vehicle | A topical drop of vehicle (minus active) ophthalmic solution. |
Timeline
- Start date
- 2023-02-27
- Primary completion
- 2023-12-30
- Completion
- 2024-03-30
- First posted
- 2023-01-25
- Last updated
- 2024-07-11
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05695781. Inclusion in this directory is not an endorsement.