Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment

BRIM Biotechnology

Status and phase

Completed

Phase 3

Phase 2

Conditions

Dry Eye Syndrome

Treatments

Drug: BRM421

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04343287

BRM421-18-C001-PR

Details and patient eligibility

About

The objective of this study is to compare the safety and efficacy of BRM421 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.

Full description

This is a multi-center, double-masked, randomized, placebo-controlled, phase 2/3 study with approximately 200 subjects. (around 100 subjects per treatment arm).

Enrollment

220 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 for at least 6 months prior to enrollment;
Have a history of use of 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; acceptable methods of contraception