Back to resultsSafety and Efficacy of BRM421 for Dry Eye Syndrome
Primary Purpose
Dry Eye Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BRM421
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndrome
Eligibility 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
Sites / Locations
- Central Maine Eye Care
- Andover Eye Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
BRM421 Ophthalmic Solution
Placebo
Arm Description
The active control with BRM421 solution
The vehicle solution
Outcomes
Primary Outcome Measures
Sign: Corneal fluorescein staining score
Symptom: Ocular discomfort score
Secondary Outcome Measures
Tear film break-up time
Conjunctival Redness
Ocular Surface Disease Index (OSDI)©
Full Information
NCT ID
NCT03066219
First Posted
February 23, 2017
Last Updated
November 20, 2017
Sponsor
BRIM Biotechnology Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03066219
Brief Title
Safety and Efficacy of BRM421 for Dry Eye Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 7, 2017 (Actual)
Primary Completion Date
May 20, 2017 (Actual)
Study Completion Date
June 28, 2017 (Actual)
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
5. 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.
Detailed Description
This is a multi-center, double-masked, randomized, vehicle-controlled, phase 2 study in approximately 150 subjects. (75 per treatment arm).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
157 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BRM421 Ophthalmic Solution
Arm Type
Active Comparator
Arm Description
The active control with BRM421 solution
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The vehicle solution
Intervention Type
Drug
Intervention Name(s)
BRM421
Intervention Description
A topical solution of BRIM421 ophthalmic drops
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
vehicle ophthalmic drops
Primary Outcome Measure Information:
Title
Sign: Corneal fluorescein staining score
Time Frame
Up to 4 weeks
Title
Symptom: Ocular discomfort score
Time Frame
Up to 4 weeks
Secondary Outcome Measure Information:
Title
Tear film break-up time
Time Frame
Up to 4 weeks
Title
Conjunctival Redness
Time Frame
Up to 4 weeks
Title
Ocular Surface Disease Index (OSDI)©
Time Frame
Up to 4 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 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
Facility Information:
Facility Name
Central Maine Eye Care
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of BRM421 for Dry Eye Syndrome
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