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

ConditionsDry Eye Disease (DED)Keratoconjunctivitis Sicca

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

BRM421 Ophthalmic Solution, 0.03%
Drug
A topical drop of 0.03% BRM421 ophthalmic solution.
Artificial Tear
Drug
A topical drop of Artificial Tear.
BRM421 Ophthalmic Solution, 0.06%
Drug
A topical drop of 0.06% BRM421 ophthalmic solution.

Treatment groups

99 Participants

are divided into 3 treatment groups

Group A: Artificial TearOther 1 intervention

Group B: BRM421 Ophthalmic Solution, 0.03%Active comparator 1 intervention

Group C: BRM421 Ophthalmic Solution, 0.06%Active comparator 1 intervention

Trial outcomes

Primary outcomes

Change from baseline in total corneal fluorescein staining (tCFS) score

Total corneal fluorescein staining (tCFS) score by using NEI Scale (0-20, higher scores mean a worse outcome)

Time frame

6 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BRIM Biotechnology Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: