Assessment of the Safety and Efficacy of BRM421 Ophthalmic Solutions in Dry Eye Subjects.

BRIM Biotechnology

Status and phase

Completed

Phase 3

Conditions

Dry Eye Disease

Treatments

Drug: BRM421 Ophthalmic Solution

Drug: Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT05695781

BRM421-22-C001-PR

Details and patient eligibility

About

The objective of this study is to compare the safety and efficacy of BRM421 OS to vehicle for the treatment of the signs and symptoms of dry eye disease.

Enrollment

740 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Be at least 18 years of age;
Provide written informed consent;
Have a reported history of dry eye prior to enrollment;
Have a history of use or desire to use eye drops;

Exclusion criteria

Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
Have used any eye drops within 2 hours of Visit 1;
Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
Be a woman of childbearing potential who is not using an acceptable means of birth control;