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Not yet recruiting NCT07078955

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

Phase II Interventional Dry Eye Disease (DED) Keratoconjunctivitis Sicca

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BRM421 Ophthalmic Solution, 0.03%, Artificial Tear, BRM421 Ophthalmic Solution, 0.06%.
Who it may be relevant to
Registry conditions: Dry Eye Disease (DED), Keratoconjunctivitis Sicca. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug BRM421 Ophthalmic Solution, 0.03%
    A topical drop of 0.03% BRM421 ophthalmic solution.
  • Drug Artificial Tear
    A topical drop of Artificial Tear.
  • Drug BRM421 Ophthalmic Solution, 0.06%
    A topical drop of 0.06% BRM421 ophthalmic solution.

Primary outcome measures

  • Change from baseline in total corneal fluorescein staining (tCFS) score [Time frame: 6 weeks]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • New Taipei Municipal TuCheng Hospital — New Taipei City

Identifiers

NCT: NCT07078955 · BRM421-24-C001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗