Safety and Efficacy of BRM421 for Dry Eye Syndrome

A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of BRM421 Ophthalmic Solution in Subjects With Dry Eye Using a Controlled Adverse Environment (CAE®) Model

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Drug: Placebo; Drug: BRM421

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maine
    • Lewiston, Maine, United States, 04240
      • Central Maine Eye Care
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BRM421 Ophthalmic Solution; The active control with BRM421 solution	Drug: BRM421; 0.03%(w/v) BRIM421 ophthalmic solution
Placebo Comparator: Placebo; The vehicle solution	Drug: Placebo; vehicle ophthalmic drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; = intermittent awareness; = constant awareness; = intermittent discomfort; = constant discomfort	change from baseline to week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tear Film Break-up Time	The examiner was instilled 5 uL of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. With the aid of a slit-lamp, the examiner monitored the integrity of the tear film, noting the time (seconds) it takes to form micelles from the time that the eye is opened.	change from baseline to week 4
Conjunctival Redness	Conjunctival redness was graded according to the following scale: Half (0.5) unit increments may be used. None 0 = Normal, without vasodilation Trace 1 = Trace ciliary or conjunctival vasodilation Mild 2 = Broad ciliary vasodilation; Moderate 3 = Broad ciliary and slight, horizontal conjunctival vasodilation Severe 4 = Broad ciliary and prominent, horizontal conjunctival vasodilation	change from baseline to week 4
Ocular Surface Disease Index (OSDI)©	OSDI scores was subjectively graded by the subjects according to the Ocular Surface and Disease Index (OSDI) Scale. Patients scored each question from 0 to 4 (higher score means more severe), and the OSDI score is the sum of total 12 questions. The score range is 0 (minimum) to 48 (maximum).	change from baseline to week 4

Collaborators and Investigators

• Sponsor: BRIM Biotechnology Inc.
• Investigators: Principal Investigator: John Lonsdale, MD, Central Maine Eye Care; Principal Investigator: Gail Torkildsen, MD, Andover Eye Associates

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2017
• Primary Completion (Actual): May 20, 2017
• Study Completion (Actual): June 28, 2017

Study Registration Dates

• First Submitted: February 23, 2017
• First Submitted That Met QC Criteria: February 23, 2017
• First Posted (Actual): February 28, 2017

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: BRM421-16-C001-PR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No