Neurotrophic Keratitis
Conditions
Brief 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.
Interventions
DRUGBRM424 Ophthalmic Solution - Dose1
A topical drop of BRM424 ophthalmic solution.
DRUGBRM424 Ophthalmic Solution - Dose2
A topical drop of BRM424 ophthalmic solution.
Sponsors
BRIM Biotechnology Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, Randomized Study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining | at or before 4 weeks |
Countries
United States
Outcome results
None listed