Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment

• ClinicalTrials.gov Identifier: NCT04343287
• Recruitment Status: Recruiting
• First Posted: April 13, 2020
• Last Update Posted: July 10, 2020
• Sponsor: BRIM Biotechnology Inc.
• Collaborator: ORA, Inc.
• Information provided by (Responsible Party): BRIM Biotechnology Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Dry Eye Syndrome	Drug: BRM421; Drug: Placebo	Phase 2; Phase 3

Detailed Description:

This is a multi-center, double-masked, randomized, placebo-controlled, phase 2/3 study with approximately 200 subjects. (around 100 subjects per treatment arm).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Double Masking
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: January 15, 2020
• Estimated Primary Completion Date: July 30, 2020
• Estimated Study Completion Date: August 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: BRM421 Ophthalmic Solution; A topical solution of BRIM421 ophthalmic drops	Drug: BRM421; The active control with BRM421 solution
Placebo Comparator: Placebo; A vehicle ophthalmic drops	Drug: Placebo; The vehicle solution

Outcome Measures

Primary Outcome Measures :

1. Sign: Corneal Fluorescein Staining Score [ Time Frame: 2 weeks ]
   Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The staining was graded with the Ophthalmic Research Associates, Inc. (ORA) scale. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining/none; 1=occasional/trace; 2=countable/mild; 3=uncountable, but not confluent/moderate; 4=confluent/severe) with 0.5 point increments, and lower score indicates a better outcome.
2. Symptom: Ocular dryness score [ Time Frame: 2 weeks ]
   Eye dryness score was scored on a Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire ranges from 0-5 (0=None; 5=Worst).

Secondary Outcome Measures :

1. Tear Film Break-up Time [ Time Frame: up to 2 weeks ]
   Tear Film Break-up Time measurement
2. Conjunctival Redness [ Time Frame: up to 2 weeks ]
   Conjunctival Redness assessment
3. Schirmer's Test [ Time Frame: 2 weeks ]
   Unanesthetized Schirmer's Test
4. Ocular Surface Disease Index (OSDI) [ Time Frame: up to 2 weeks ]
   The OSDI is a 12-question validated questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI scoring scale ranges from 0 to 100. The lower the score, the more symptomatic relief from dry eye symptoms a patient experiences. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates a perceived improvement in ocular comfort.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Erin Chang; 886-02-26598586 ext 119; erin.chang@brimbiotech.com

Locations

United States, California

Eye Research Foundation; Recruiting

Newport Beach, California, United States, 92663

Contact: Wirta L David, MD

United States, Indiana

Midwest Cornea Associates, LLC; Recruiting

Indianapolis, Indiana, United States, 46290

Contact: Blair Boehmer, MD

United States, Massachusetts

Andover Eye Associates; Recruiting

Andover, Massachusetts, United States, 01810

Contact: Gail Torkildsen, MD

United States, Tennessee

Total Eye Care; Recruiting

Memphis, Tennessee, United States, 38119

Contact: Eugene B McLaurin, MD

Sponsors and Collaborators

BRIM Biotechnology Inc.

ORA, Inc.

More Information

• Responsible Party: BRIM Biotechnology Inc.
• ClinicalTrials.gov Identifier: NCT04343287
• Other Study ID Numbers: BRM421-18-C001-PR
• First Posted: April 13, 2020
• Last Update Posted: July 10, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Keratoconjunctivitis Sicca; Dry Eye Syndromes; Eye Diseases; Syndrome; Disease; Pathologic Processes; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Lacrimal Apparatus Diseases