An Open-Label, Multi-Center, Phase 2 Dose Ranging Study of BRM424 Ophthalmic Solution in Patients With Neurotrophic Keratitis (NK)
BRIM Biotechnology Inc.
Summary
The objective of this study is to obtain initial efficacy of BRM424 in patients with Stage 2 and Stage 3 NK and evaluate safety and tolerability.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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;
Interventions
- DrugBRM424 Ophthalmic Solution - Dose1
A topical drop of BRM424 ophthalmic solution.
- DrugBRM424 Ophthalmic Solution - Dose2
A topical drop of BRM424 ophthalmic solution.
Location
- Wilmington EyeLeland, North Carolina