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

Description

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.

Conditions

Neurotrophic Keratitis

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Study Overview

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Study Details

Study overview

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.

An Open-Label, Multi-Center, Phase 2 Dose Ranging Study of BRM424 Ophthalmic Solution in Patients With Neurotrophic Keratitis (NK)

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

Condition
Neurotrophic Keratitis
Intervention / Treatment

-

Contacts and Locations

Leland

Wilmington Eye, Leland, North Carolina, United States, 28451

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Be at least 18 years of age;
  • * Provide written informed consent;
  • * Patients with NK Stage 2 (PED) or Stage 3 (corneal ulcer);
  • * 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;

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BRIM Biotechnology Inc.,

Study Record Dates

2025-11-30