Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment

NCT04343287 | Completed Phase 2 Results FDA Drug

• 1 other identifier: BRM421-18-C001-PR
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 4

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.

Conditions

Dry Eye Syndrome

Outcome Measures

Primary Outcomes (2)

• Ocular Sign: Change From Baseline in Total Corneal Staining Score to Day 14

  Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. Ora Calibra® Scale from 0 to 4 with the use of half grade (0.5) increments, where grade 0 = None and 4 = Severe. Total corneal staining score was the sum of all three regions (Inferior, Central and Superior), the score range is from 0 (minimum) to 12 (maximum).

  change from baseline to 2 weeks

• Ocular Symptom: Change From Baseline in Patient-Reported Ocular Dryness Score to Day 14, Using Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire

  Ocular dryness from the Ora Calibra® Ocular Discomfort \& 4-Symptom Questionnaire was assessed at the subject level in regard to how both eyes felt. The Ora Calibra® Ocular Discomfort \& 4-Symptom Questionnaire was used, which included rating the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Each symptom rating ranged from 0 to 5, where 0 = None and 5 = Worst.

  change from baseline to 2 weeks

Secondary Outcomes (1)

• Eye Dryness: Change From Baseline in Patient-Reported Ocular Symptom to Day 8, Using Visual Analog Scale (VAS)

  change from baseline to 1 week

Study Arms (2)

BRM421 Ophthalmic Solution

ACTIVE COMPARATOR

A topical solution of BRIM421 ophthalmic drops

Drug: BRM421

Placebo

PLACEBO COMPARATOR

A vehicle ophthalmic drops

Drug: Placebo

Interventions

BRM421 DRUG

The active control with BRM421 solution

BRM421 Ophthalmic Solution

Placebo DRUG

The vehicle solution

Placebo

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 for at least 6 months prior to enrollment;
• Have a history of use of 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; acceptable methods of contraception

Sponsors & Collaborators

• BRIM Biotechnology Inc.: lead

Study Sites (4)

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Midwest Cornea Associates, LLC

Indianapolis, Indiana, 46290, United States

Location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Total Eye Care

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Alin Ning, Associate Director, Product Development Department
• Organization: BRIM Biotechnology, Inc.

alin.ning@brimbiotech.com

+886-2659-8586

Study Officials

• Gail Torkildsen, MD

  Andover Eye Associates

  PRINCIPAL INVESTIGATOR

• Blair Boehmer, MD

  Midwest Cornea Associates, LLC.

  PRINCIPAL INVESTIGATOR

• David Wirta, MD

  Eye Research Foundation

  PRINCIPAL INVESTIGATOR

• Eugene B McLaurin, MD

  Total Eye Care, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 13, 2020
• Study Start: January 15, 2020
• Primary Completion: June 23, 2020
• Study Completion: June 23, 2020
• Last Updated: May 1, 2026
• Results First Posted: October 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)