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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05695781

Enrollment

740

Registered

2023-01-25

Start date

2023-02-27

Completion date

2024-03-30

Last updated

2024-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Disease

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.

Interventions

DRUGBRM421 Ophthalmic Solution

A topical drop of BRM421 ophthalmic solution.

DRUGVehicle

A topical drop of vehicle (minus active) ophthalmic solution.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Intervention model description

Double Masking

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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;

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026