A Dose Regimen Study of BRM421 Ophthalmic Solution in Patients With Dry Eye Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-03-31

Brief Summary

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To evaluate the safety and efficacy of BRM421 Ophthalmic Solution compared to artificial tear for treatment of the signs and symptoms of dry eye disease (DED)

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Detailed Description

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Conditions

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Dry Eye Disease (DED) Keratoconjunctivitis Sicca

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Artificial Tear

Group Type OTHER

Artificial Tear

Intervention Type DRUG

A topical drop of Artificial Tear.

BRM421 Ophthalmic Solution, 0.03%

Group Type ACTIVE_COMPARATOR

BRM421 Ophthalmic Solution, 0.03%

Intervention Type DRUG

A topical drop of 0.03% BRM421 ophthalmic solution.

BRM421 Ophthalmic Solution, 0.06%

Group Type ACTIVE_COMPARATOR

BRM421 Ophthalmic Solution, 0.06%

Intervention Type DRUG

A topical drop of 0.06% BRM421 ophthalmic solution.

Interventions

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BRM421 Ophthalmic Solution, 0.03%

A topical drop of 0.03% BRM421 ophthalmic solution.

Intervention Type DRUG

Artificial Tear

A topical drop of Artificial Tear.

Intervention Type DRUG

BRM421 Ophthalmic Solution, 0.06%

A topical drop of 0.06% BRM421 ophthalmic solution.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Are ≥18 years of age;
* Are willing and able to comply with all study procedures and restrictions and the visit schedule;
* Have a self-reported history of dry eye prior to enrollment;
* If a woman of childbearing potential (WOCBP): are non-lactating, have a negative urine pregnancy test (UPT), and agree to use an acceptable form of contraception for the duration of the study;

Exclusion Criteria

* Within 3 months prior to Visit 1, have participated in any other investigational study or used an investigational product or device;
* Have any history of organ or bone marrow transplant, immunodeficiency disorder, human immunodeficiency virus, or hepatitis C, or any evidence of acute active hepatitis A (anti-hepatitis A virus immunoglobulin M);
* Have any significant illness or condition that, in the opinion of the Investigator, could affect the study outcome measures. Such illnesses include (but are not limited to) Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, severe cardiopulmonary disease, poorly controlled hypertension or diabetes, or drug/alcohol addiction;
* Within 12 months prior to Visit 1, have undergone any ocular surgical procedure, including laser-assisted in situ keratomileusis (LASIK) or a similar corneal refractive surgery;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No