Back to resultsAssessment of the Safety and Efficacy of BRM421 Ophthalmic Solutions in Dry Eye Subjects.
Primary Purpose
Dry Eye Disease
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
BRM421 Ophthalmic Solution
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Disease
Eligibility Criteria
Inclusion Criteria: Be at least 18 years of age; Provide written informed consent; Have a reported history of dry eye prior to enrollment; Have a history of use or desire to use 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;
Sites / Locations
- Andover Eye AssociatesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
BRM421 Ophthalmic Solution
Vehicle
Arm Description
Outcomes
Primary Outcome Measures
Ocular Sign: Change From Baseline in Total Corneal Fluorescein Staining Score
0-12 Ora scale, higher scores mean a worse outcome.
Ocular Symptom: Change From Baseline in Visual Analog Scale (VAS)
0-100 Visual Analog Scale, higher scores mean a worse discomfort.
Secondary Outcome Measures
Full Information
NCT ID
NCT05695781
First Posted
January 13, 2023
Last Updated
September 15, 2023
Sponsor
BRIM Biotechnology Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05695781
Brief Title
Assessment of the Safety and Efficacy of BRM421 Ophthalmic Solutions in Dry Eye Subjects.
Official Title
A Multi-Center, Randomized, Double Masked, Vehicle 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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BRIM Biotechnology Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The objective of this study is to compare the safety and efficacy of BRM421 OS to vehicle for the treatment of the signs and symptoms of dry eye disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Double Masking
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
732 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BRM421 Ophthalmic Solution
Arm Type
Active Comparator
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BRM421 Ophthalmic Solution
Intervention Description
A topical drop of BRM421 ophthalmic solution.
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
A topical drop of vehicle (minus active) ophthalmic solution.
Primary Outcome Measure Information:
Title
Ocular Sign: Change From Baseline in Total Corneal Fluorescein Staining Score
Description
0-12 Ora scale, higher scores mean a worse outcome.
Time Frame
1-2 weeks
Title
Ocular Symptom: Change From Baseline in Visual Analog Scale (VAS)
Description
0-100 Visual Analog Scale, higher scores mean a worse discomfort.
Time Frame
1-2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be at least 18 years of age;
Provide written informed consent;
Have a reported history of dry eye prior to enrollment;
Have a history of use or desire to use 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alin Ning
Phone
+886-2-26598586
Email
alin.ning@brimbiotech.com
Facility Information:
Facility Name
Andover Eye Associates
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alin Ning
12. IPD Sharing Statement
Learn more about this trial
Assessment of the Safety and Efficacy of BRM421 Ophthalmic Solutions in Dry Eye Subjects.
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