A Dose Regimen Study of BRM421 Ophthalmic Solution in Patients With Dry Eye Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBRIM Biotechnology Inc.
About this trial
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)
Eligibility criteria
Qualifiers
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;
Disqualifiers
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
Treatments tested in this trial
- BRM421 Ophthalmic Solution, 0.03%
- Artificial Tear
- BRM421 Ophthalmic Solution, 0.06%
Treatment groups
99 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov