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

Not Applicable

Not yet recruiting

• Conditions: Dry Eye Disease (DED); Keratoconjunctivitis Sicca
• Interventions: Drug: Vehicle Ophthalmic Solution; Drug: BRM421 Ophthalmic Solution, 0.03%; Drug: BRM421 Ophthalmic Solution, 0.06%

• Registration Number: NCT07078955
• Lead Sponsor: BRIM Biotechnology Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-14
• Study First Submitted QC: 2025-07-14
• Study First Posted: 2025-07-22
• Last Update Submitted: 2025-07-25
• Last Update Posted: 2025-07-29
• Study Start: 2025-11-01
• Primary Completion: 2026-09
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 99

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;
• Within 2 hours prior to Visit 1, have used artificial tears or any other topical ophthalmic preparations not mentioned above. These treatments are also prohibited for the duration of the study;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle ophthalmic solution	Vehicle Ophthalmic Solution	-
BRM421 Ophthalmic Solution, 0.03%	BRM421 Ophthalmic Solution, 0.03%	-
BRM421 Ophthalmic Solution, 0.06%	BRM421 Ophthalmic Solution, 0.06%	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in total corneal fluorescein staining (tCFS) score	6 weeks	Total corneal fluorescein staining (tCFS) score by using NEI Scale (0-20, higher scores mean a worse outcome)

Trial Locations

Locations (1)

New Taipei Municipal TuCheng Hospital; 🇨🇳 New Taipei City, Taiwan