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

NCT05695781 | Completed Phase 3 FDA Drug

• 1 other identifier: BRM421-22-C001-PR
• Study Type: interventional
• Target: 740
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

• Ocular Sign: Change From Baseline in Total Corneal Fluorescein Staining Score

  0-12 Ora scale, higher scores mean a worse outcome.

  1-2 weeks

• Ocular Symptom: Change From Baseline in Visual Analog Scale (VAS)

  0-100 Visual Analog Scale, higher scores mean a worse discomfort.

  1-2 weeks

Study Arms (2)

BRM421 Ophthalmic Solution

ACTIVE COMPARATOR

Drug: BRM421 Ophthalmic Solution

Vehicle

PLACEBO COMPARATOR

Drug: Vehicle

Interventions

BRM421 Ophthalmic Solution DRUG

A topical drop of BRM421 ophthalmic solution.

BRM421 Ophthalmic Solution

Vehicle DRUG

A topical drop of vehicle (minus active) ophthalmic solution.

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• BRIM Biotechnology Inc.: lead

Study Sites (1)

Andover Eye Associates

Warwick, Rhode Island, 02886, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double Masking

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 25, 2023
• Study Start: February 27, 2023
• Primary Completion: December 30, 2023
• Study Completion: March 30, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Locations

US (1)