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

Dry Eye Disease Clinical Trial

Official title:

A Multi-Center, Randomized, Double Masked, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of BRM421 Ophthalmic Solution in Subjects With Dry Eye Using a Controlled Adverse Environment (CAE®) Model

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05695781
• Other study ID #: BRM421-22-C001-PR
• Status: Recruiting
• Phase: Phase 3
• Start date: February 27, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: September 2023
• Source: BRIM Biotechnology Inc.
• Contact: Alin Ning
• Phone: +886-2-26598586
• Email: alin.ning[@]brimbiotech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 732
• Est. completion date: March 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• BRM421 Ophthalmic Solution
A topical drop of BRM421 ophthalmic solution.
• Vehicle
A topical drop of vehicle (minus active) ophthalmic solution.

Locations

Country	Name	City	State
United States	Andover Eye Associates	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
BRIM Biotechnology Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Sign: Change From Baseline in Total Corneal Fluorescein Staining Score	0-12 Ora scale, higher scores mean a worse outcome.	1-2 weeks
Primary	Ocular Symptom: Change From Baseline in Visual Analog Scale (VAS)	0-100 Visual Analog Scale, higher scores mean a worse discomfort.	1-2 weeks