Phase 2
N=157
Safety and Efficacy of BRM421 for Dry Eye Syndrome
Dry Eye Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03066219 ↗Enrolled (actual)
157
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Sign: Corneal Fluorescein Staining Score — -1.06; -1.16 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BRM421 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BRIM Biotechnology Inc.
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sign: Corneal Fluorescein Staining Score |
-1.06; -1.16 | — |
| PRIMARY Symptom: Ocular Discomfort Score |
0.41; 0.16 | — |
| SECONDARY Tear Film Break-up Time |
-0.165; 0.183 | — |
| SECONDARY Conjunctival Redness |
-0.14; -0.1 | — |
| SECONDARY Ocular Surface Disease Index (OSDI)© |
-3.89; -3.04 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03066219). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.