Safety and Efficacy of BRM421 for Dry Eye Syndrome

Phase 2

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Drug: BRM421; Drug: Placebo

• Registration Number: NCT03066219
• Lead Sponsor: BRIM Biotechnology Inc.

Brief Summary

The objective of this study is to compare the safety and efficacy of BRM421 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.

Detailed Description

This is a multi-center, double-masked, randomized, vehicle-controlled, phase 2 study in approximately 150 subjects. (75 per treatment arm).

Study Timeline

• Study Start: 2017-02-07
• Study First Submitted: 2017-02-23
• Study First Submitted QC: 2017-02-23
• Study First Posted: 2017-02-28
• Primary Completion: 2017-05-20
• Study Completion: 2017-06-28
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-20
• Last Update Posted: 2017-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

Inclusion Criteria

• Be at least 18 years of age;
• Provide written informed consent;
• Have a reported history of dry eye for at least 6 months prior to enrollment;
• Have a history of use of 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; acceptable methods of contraception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BRM421 Ophthalmic Solution	BRM421	The active control with BRM421 solution
Placebo	Placebo	The vehicle solution

Primary Outcome Measures

Name	Time	Method
Symptom: Ocular discomfort score	Up to 4 weeks
Sign: Corneal fluorescein staining score	Up to 4 weeks

Secondary Outcome Measures

Name	Time	Method
Conjunctival Redness	Up to 4 weeks
Tear film break-up time	Up to 4 weeks
Ocular Surface Disease Index (OSDI)©	Up to 4 weeks

Trial Locations

Locations (2)

Andover Eye Associates; 🇺🇸 Andover, Massachusetts, United States

Central Maine Eye Care; 🇺🇸 Lewiston, Maine, United States