Phase 3
Completed N=220
Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment
Source: ClinicalTrials.gov NCT04343287 ↗Enrolled (actual)
220
Serious AEs
0.4%
Results posted
Oct 2021
Primary outcomePrimary: Ocular Sign: Change From Baseline in Total Corneal Staining Score to Day 14 — -1; -0.68 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Sign: Change From Baseline in Total Corneal Staining Score to Day 14 |
-1; -0.68 | — |
| PRIMARY Ocular Symptom: Change From Baseline in Patient-Reported Ocular Dryness Score to Day 14, Using Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire |
-0.3; -0.5 | — |
| SECONDARY Eye Dryness: Change From Baseline in Patient-Reported Ocular Symptom to Day 8, Using Visual Analog Scale (VAS) |
-8.4; -3.7 | — |
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 (NCT04343287). 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. Informational only — not medical advice.