Safety and Efficacy of BRM421 for Dry Eye Syndrome

This is a multi-center, double-masked, randomized, vehicle-controlled, phase 2 study in
approximately 150 subjects. (75 per treatment arm).

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