Safety and Efficacy of BRM421 for Dry Eye Syndrome

NCT03066219 | Completed Phase 2 Results FDA Drug

• 1 other identifier: BRM421-16-C001-PR
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 2

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)

• Sign: Corneal Fluorescein Staining Score

  The staining was graded with the Ora Calibra® Corneal and Conjunctival Staining Scale. The ocular surface was divided into three regions, including superior, central and inferior region. The following scale was used to grade staining of the each region. Half (0.5) grade increments may be used. The total score of corneal fluorescein staining was calculated as the sum of three regions, the score range is 0 (minimum) to 12 (maximum). None 0 = no staining Trace 1 = occasional Mild 2 = countable Moderate 3 = uncountable, but not confluent Severe 4 = confluent

  change from baseline to week 4

• Symptom: Ocular Discomfort Score

  Ocular discomfort scores was subjectively graded by the subjects according to the following Ora Calibra® Ocular Discomfort Scale, rating each eye separately, the score range is 0 (minimum) to 4 (maximum). 0 = no discomfort 1. = intermittent awareness 2. = constant awareness 3. = intermittent discomfort 4. = constant discomfort

  change from baseline to week 4

Secondary Outcomes (3)

• Tear Film Break-up Time

  change from baseline to week 4

• Conjunctival Redness

  change from baseline to week 4

• Ocular Surface Disease Index (OSDI)©

  change from baseline to week 4

Study Arms (2)

BRM421 Ophthalmic Solution

ACTIVE COMPARATOR

The active control with BRM421 solution

Drug: BRM421

Placebo

PLACEBO COMPARATOR

The vehicle solution

Drug: Placebo

Interventions

BRM421 DRUG

0.03%(w/v) BRIM421 ophthalmic solution

BRM421 Ophthalmic Solution

Placebo DRUG

vehicle ophthalmic drops

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 (2)

Central Maine Eye Care

Lewiston, Maine, 04240, United States

Location

Andover Eye Associates

Andover, Massachusetts, 01810, 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

alin.ning@brimbiotech.com

+886 226598586

Study Officials

• Gail Torkildsen, MD

  Andover Eye Associates

  PRINCIPAL INVESTIGATOR

• John Lonsdale, MD

  Central Maine Eye Care

  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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: February 28, 2017
• Study Start: February 7, 2017
• Primary Completion: May 20, 2017
• Study Completion: June 28, 2017
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2019-10

Locations

US (2)