Actively Recruiting
An Open-Label, Multi-Center, Phase 2 Dose Ranging Study of BRM424 Ophthalmic Solution in Patients With Neurotrophic Keratitis
Led by BRIM Biotechnology Inc. · Updated on 2024-10-28
12
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial is studying BRM424 ophthalmic solution in patients with Neurotrophic Keratitis (NK), specifically those with Stage 2 and Stage 3 of the condition. The study aims to evaluate the initial effectiveness of BRM424 in healing persistent epithelial defects (PED) or corneal ulcers and to assess its safety and tolerability. The trial is a Phase 2, randomized, open-label study sponsored by BRIM Biotechnology Inc. Participants will receive one of two doses of BRM424 ophthalmic solution, administered as topical eye drops. The study does not include a placebo group and involves two active comparator arms. The treatment period is 28 days, during which patients will use the assigned dose of BRM424. The study is conducted across multiple centers and does not involve masking or blinding. Participants will be monitored for healing progress using corneal fluorescein staining to assess complete healing of the PED or corneal ulcer within four weeks. Safety and tolerability assessments will also be conducted throughout the treatment period. The trial will track the proportion of patients achieving complete healing as the primary outcome measure. Participation is expected to last at least four weeks, with evaluations focusing on eye health and treatment response.
CONDITIONS
Brief Title
Assessment of the Initial Efficacy and Safety of BRM424 Ophthalmic Solutions in Patients With Neurotrophic Keratitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 18 years of age
- Provide written informed consent
- Have Stage 2 (Persistent Epithelial Defect) or Stage 3 (corneal ulcer) Neurotrophic Keratitis
You will not qualify if you...
- Have any active ocular infection (bacterial, viral, fungal, or protozoal) or active eye inflammation not related to Neurotrophic Keratitis
- Anticipated need to use therapeutic contact lenses or wear contact lenses for vision correction during the 28-day treatment period in the affected eye(s)
- Women of childbearing potential not using an acceptable method of birth control
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks
Participants receive BRM424 ophthalmic solution as a topical eye drop to treat Neurotrophic Keratitis.
Weekly visits for up to 4 weeks
Trial Site Locations
Total: 1 location
1
Wilmington Eye
Leland, North Carolina, United States, 28451
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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