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

A Phase 2, Multicenter, Randomized, Open-Labeled, Artificial Tear-Controlled, 6-Week Clinical Study to Assess the Dose Regimen, Safety and Efficacy of BRM421 Ophthalmic Solution in Patients With Dry Eye Disease

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07078955

Enrollment

Registered

2025-07-22

Start date

2025-12-31

Completion date

2027-03-31

Last updated

2025-10-20

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

Conditions

Dry Eye Disease (DED), Keratoconjunctivitis Sicca

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)

Interventions

DRUGBRM421 Ophthalmic Solution, 0.03%

A topical drop of 0.03% BRM421 ophthalmic solution.

DRUGArtificial Tear

A topical drop of Artificial Tear.

DRUGBRM421 Ophthalmic Solution, 0.06%

A topical drop of 0.06% BRM421 ophthalmic solution.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

Taiwan

Contacts

Primary ContactNing Alin Associate Director

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

Outcome results

None listed

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