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

NCT07078955 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: BRM421-24-C001
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Dry Eye Disease (DED); Keratoconjunctivitis Sicca

Outcome Measures

Primary Outcomes (1)

• Change from baseline in total corneal fluorescein staining (tCFS) score

  Total corneal fluorescein staining (tCFS) score by using NEI Scale (0-20, higher scores mean a worse outcome)

  6 weeks

Study Arms (3)

Artificial Tear

OTHER

Drug: Artificial Tear

BRM421 Ophthalmic Solution, 0.03%

ACTIVE COMPARATOR

Drug: BRM421 Ophthalmic Solution, 0.03%

BRM421 Ophthalmic Solution, 0.06%

ACTIVE COMPARATOR

Drug: BRM421 Ophthalmic Solution, 0.06%

Interventions

BRM421 Ophthalmic Solution, 0.03% DRUG

A topical drop of 0.03% BRM421 ophthalmic solution.

BRM421 Ophthalmic Solution, 0.03%

Artificial Tear DRUG

A topical drop of Artificial Tear.

Artificial Tear

BRM421 Ophthalmic Solution, 0.06% DRUG

A topical drop of 0.06% BRM421 ophthalmic solution.

BRM421 Ophthalmic Solution, 0.06%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• BRIM Biotechnology Inc.: lead

Study Sites (1)

New Taipei Municipal TuCheng Hospital

New Taipei City, Taiwan

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Keratoconjunctivitis Sicca

Interventions

Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases

Intervention Hierarchy (Ancestors)

Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Central Study Contacts

Ning Alin Associate Director

CONTACT

+886-2-26598586; alin.ning@brimbiotech.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 22, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)