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NCT04343287 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment
A Phase 2 study of Dry Eye Syndrome, sponsored by BRIM Biotechnology.
- Completed
- Registry status
- Phase 2
- Development phase
- 220
- Enrollment target
- 4
- Study locations
NCT04343287: Completed Phase 2 study of Dry Eye Syndrome, sponsored by BRIM Biotechnology.
NCT04343287 is a Phase 2 study of Dry Eye Syndrome that has completed, run by BRIM Biotechnology. The registered enrollment target is 220 participants, above the 143-participant average among 10 other Dry Eye Syndrome trials with a reported enrollment target (54% higher). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04343287, a Phase 2 study of Dry Eye Syndrome, has completed, sponsored by BRIM Biotechnology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 220 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. Ora Calibra® Scale from 0 to 4 with the use of half grade (0.5) increments, where grade 0 = None and 4 = Severe. Total corneal staining score was the sum of all three regions (Inferior, Central and Superior), the score range is from 0 (minimum) to 12 (maximum).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BRM421
Study Locations (4)
California
- Eye Research Foundation - Newport Beach
Indiana
- Midwest Cornea Associates, LLC - Indianapolis
Massachusetts
- Andover Eye Associates - Andover
Tennessee
- Total Eye Care - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2020-01-15 |
| Est. Completion | 2020-06-23 |
| Phase | Phase 2 |
What the finished NCT04343287 record still lists
NCT04343287 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, above the 143-participant average among 10 other Dry Eye Syndrome trials with a reported enrollment target (54% higher).
The record links to 1 condition, with Dry Eye Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04343287 reports a single indexed study location in California, Indiana, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04343287 about?
NCT04343287 is a clinical study titled "Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment". 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.
What is the current status of trial NCT04343287?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 220 participants. The study started on 2020-01-15. Estimated completion is 2020-06-23.
What conditions does trial NCT04343287 study?
This clinical trial studies the following conditions: Dry Eye Syndrome.
What interventions are being tested in trial NCT04343287?
The interventions under investigation include: Placebo (DRUG), BRM421 (DRUG).
Who is sponsoring clinical trial NCT04343287?
This trial is sponsored by BRIM Biotechnology, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04343287 being conducted?
This trial has 4 study locations across California, Indiana, Massachusetts, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dry Eye Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04343287's enrollment target sits among peer trials
220 3rd of 10 higher than 8 of 10 other Dry Eye Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dry Eye Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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