NCT05927428PHASE2Recruiting
Assessment of the Initial Efficacy and Safety of BRM424 Ophthalmic Solutions in Patients With Neurotrophic Keratitis
BRIM Biotechnology Inc.
Start Date
7/31/2024
Completion Date
11/30/2025
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 Criteria
Age Range: 18 years to No maximum
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
DRUG
BRM424 Ophthalmic Solution - Dose1
DRUG
BRM424 Ophthalmic Solution - Dose2
Conditions
Neurotrophic Keratitis
Locations
Wilmington Eye
Leland, North Carolina 28451
United States