---
title: Assessment of the Safety and Efficacy of BRM421 Ophthalmic Solutions in Dry Eye Subjects.
nct_id: NCT05695781
overall_status: COMPLETED
phase: PHASE3
sponsor: BRIM Biotechnology Inc.
study_type: INTERVENTIONAL
primary_condition: Dry Eye Disease
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05695781.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05695781"
ct_last_update_post_date: 2024-07-11
last_seen_at: "2026-05-12T07:16:30.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Assessment of the Safety and Efficacy of BRM421 Ophthalmic Solutions in Dry Eye Subjects.

**Official Title:** 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

**NCT ID:** [NCT05695781](https://clinicaltrials.gov/study/NCT05695781)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 740
- **Lead Sponsor:** BRIM Biotechnology Inc.
- **Conditions:** Dry Eye Disease
- **Start Date:** 2023-02-27
- **Completion Date:** 2024-03-30
- **CT.gov Last Update:** 2024-07-11

## Brief 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent;
* Have a reported history of dry eye prior to enrollment;
* Have a history of use or desire to use eye drops;

Exclusion Criteria:

* Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
* Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
* Have used any eye drops within 2 hours of Visit 1;
* Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
* Be a woman of childbearing potential who is not using an acceptable means of birth control;
```

## Arms

- **BRM421 Ophthalmic Solution** (ACTIVE_COMPARATOR)
- **Vehicle** (PLACEBO_COMPARATOR)

## Interventions

- **BRM421 Ophthalmic Solution** (DRUG) — A topical drop of BRM421 ophthalmic solution.
- **Vehicle** (DRUG) — A topical drop of vehicle (minus active) ophthalmic solution.

## Primary Outcomes

- **Ocular Sign: Change From Baseline in Total Corneal Fluorescein Staining Score** _(time frame: 1-2 weeks)_ — 0-12 Ora scale, higher scores mean a worse outcome.
- **Ocular Symptom: Change From Baseline in Visual Analog Scale (VAS)** _(time frame: 1-2 weeks)_ — 0-100 Visual Analog Scale, higher scores mean a worse discomfort.

## Locations (1)

- Andover Eye Associates, Warwick, Rhode Island, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.andover eye associates|warwick|rhode island|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05695781.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05695781*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*