Status:
COMPLETED
Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment
Lead Sponsor:
BRIM Biotechnology Inc.
Collaborating Sponsors:
ORA, Inc.
Conditions:
Dry Eye Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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, placebo-controlled, phase 2/3 study with approximately 200 subjects. (around 100 subjects per treatment arm).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2020
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04343287
Start Date
January 15 2020
End Date
June 23 2020
Last Update
October 21 2021
Active Locations (4)
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1
Eye Research Foundation
Newport Beach, California, United States, 92663
2
Midwest Cornea Associates, LLC
Indianapolis, Indiana, United States, 46290
3
Andover Eye Associates
Andover, Massachusetts, United States, 01810
4
Total Eye Care
Memphis, Tennessee, United States, 38119