Last updated: September 24, 2021
Sponsor: BRIM Biotechnology Inc.
Overall Status: Completed
Phase
2/3
Condition
Dry Eyes
Eyelid Inflammation
Sjogren's Syndrome
Treatment
N/AClinical Study ID
NCT04343287
BRM421-18-C001-PR
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
Exclusion Criteria:
- Have any clinically significant slit lamp findings at Visit 1 that may include activeblepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or activeocular allergies that require therapeutic treatment, and/or in the opinion of theinvestigator may interfere with study parameters;
- Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or activeocular inflammation at Visit 1;
- Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lensesduring the study;
- Have used any eye drops within 2 hours of Visit 1;
- Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within thelast 12 months;
- Be a woman of childbearing potential who is not using an acceptable means of birthcontrol; acceptable methods of contraception
Study Design
Total Participants: 220
Study Start date:
January 15, 2020
Estimated Completion Date:
June 23, 2020
Study Description
Connect with a study center
Eye Research Foundation
Newport Beach, California 92663
United StatesSite Not Available
Midwest Cornea Associates, LLC
Indianapolis, Indiana 46290
United StatesSite Not Available
Andover Eye Associates
Andover, Massachusetts 01810
United StatesSite Not Available
Total Eye Care
Memphis, Tennessee 38119
United StatesSite Not Available

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