Phase 2 Study to Evaluate the Safety and Effectiveness of BRM424 Eye Drops in Adults With Stage 2 or 3 Neurotrophic Keratitis

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.

Assessment of the Initial Efficacy and Safety of BRM424 Ophthalmic Solutions in Patients With Neurotrophic Keratitis