Testing BRM424 eye drops for treating neurotrophic keratitis
An Open-Label, Multi-Center, Phase 2 Dose Ranging Study of BRM424 Ophthalmic Solution in Patients With Neurotrophic Keratitis (NK)
This study is testing if BRM424 eye drops can help people with Stage 2 and Stage 3 neurotrophic keratitis feel better and improve their eye condition.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | BRIM Biotechnology Inc. Industry-sponsored |
| Locations | 1 site (Leland, North Carolina) |
| Trial ID | NCT05927428 on ClinicalTrials.gov |
What this trial studies
This study evaluates the initial efficacy and safety of BRM424 ophthalmic solutions in patients diagnosed with Stage 2 and Stage 3 neurotrophic keratitis. Participants will receive two different doses of the BRM424 solution to determine its effectiveness in improving their condition. The study aims to assess both the therapeutic benefits and tolerability of the treatment over a 28-day period. Patients will be monitored for any adverse effects during the treatment phase.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with Stage 2 or Stage 3 neurotrophic keratitis.
Not a fit: Patients with active ocular infections or inflammation unrelated to neurotrophic keratitis will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing and quality of life for patients suffering from neurotrophic keratitis.
How similar studies have performed: While this approach is novel, similar studies targeting neurotrophic keratitis have shown promise in exploring new treatment options.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be at least 18 years of age; * Provide written informed consent; * Patients with NK Stage 2 (PED) or Stage 3 (corneal ulcer); Exclusion Criteria: * Any active ocular infection (bacterial, viral, fungal or protozoal) or active ocular inflammation not related to NK; * Anticipated need to use therapeutic contact lenses or contact lens wear for refractive correction during the 28-days Treatment Period in the eye(s) with NK; * Be a woman of childbearing potential who is not using an acceptable means of birth control;
Where this trial is running
Leland, North Carolina
- Wilmington Eye — Leland, North Carolina, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.