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

BRIM Biotechnology

Status and phase: Not yet enrolling; Phase 2

Conditions: Dry Eye Disease (DED); Keratoconjunctivitis Sicca

Treatments: Drug: BRM421 Ophthalmic Solution, 0.06%; Drug: Artificial Tear; Drug: BRM421 Ophthalmic Solution, 0.03%

Study type: Interventional

Funder types: Industry

Identifiers

NCT07078955

BRM421-24-C001

Details and patient eligibility

About

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)

Enrollment: 99 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 3 patient groups

Artificial Tear

Other group

Treatment:

Drug: Artificial Tear

BRM421 Ophthalmic Solution, 0.03%

Active Comparator group

Treatment:

Drug: BRM421 Ophthalmic Solution, 0.03%

BRM421 Ophthalmic Solution, 0.06%

Active Comparator group

Treatment:

Drug: BRM421 Ophthalmic Solution, 0.06%