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

Phase 3

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: BRM421 Ophthalmic Solution; Drug: Vehicle

• Registration Number: NCT05695781
• Lead Sponsor: BRIM Biotechnology Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-13
• Study First Submitted QC: 2023-01-13
• Study First Posted: 2023-01-25
• Study Start: 2023-02-27
• Primary Completion: 2023-12-30
• Study Completion: 2024-03-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 740

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BRM421 Ophthalmic Solution	BRM421 Ophthalmic Solution	-
Vehicle	Vehicle	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Andover Eye Associates; 🇺🇸 Warwick, Rhode Island, United States