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Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04343287
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : July 10, 2020
ORA, Inc.
Information provided by (Responsible Party):
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.

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).

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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

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

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.

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04343287

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Contact: Erin Chang 886-02-26598586 ext 119

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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.
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Responsible Party: BRIM Biotechnology Inc. Identifier: NCT04343287    
Other Study ID Numbers: BRM421-18-C001-PR
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Pathologic Processes
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases