Trials / Completed
CompletedNCT04343287
Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment
A Multi-Center, Randomized, Double Masked, Placebo 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 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 220 (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 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.
Detailed description
This is a multi-center, double-masked, randomized, placebo-controlled, phase 2/3 study with approximately 200 subjects. (around 100 subjects per treatment arm).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BRM421 | The active control with BRM421 solution |
| DRUG | Placebo | The vehicle solution |
Timeline
- Start date
- 2020-01-15
- Primary completion
- 2020-06-23
- Completion
- 2020-06-23
- First posted
- 2020-04-13
- Last updated
- 2021-10-21
- Results posted
- 2021-10-21
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04343287. Inclusion in this directory is not an endorsement.