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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

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Conditions

Neurotrophic Keratitis

Locations

Wilmington Eye

Leland, North Carolina 28451

United States