Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Dry Eye Syndrome
In brief
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.
Key facts
- Study ID
- NCT04343287
- Run by
- BRIM Biotechnology Inc.
- People needed
- 220
- Starts
- 2020-01-15
- Expected to finish
- 2020-06-23
- Last updated by the study team
- 2026-05-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Eye Research Foundation — Newport Beach, California, United States
- Midwest Cornea Associates, LLC — Indianapolis, Indiana, United States
- Andover Eye Associates — Andover, Massachusetts, United States
- Total Eye Care — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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