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NCT Number: NCT05927428

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

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.

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Key information

Conditions

Neurotrophic Keratitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wilmington Eye

Leland, North Carolina, 28451, United States

Location status: Recruiting

Location contact

Crystal Wong

CONTACT

[email protected]

910-763-3601

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

BRM424 Ophthalmic Solution - Dose1

Drug

A topical drop of BRM424 ophthalmic solution.

BRM424 Ophthalmic Solution - Dose2

Drug

A topical drop of BRM424 ophthalmic solution.

Primary outcomes

  1. Proportion of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining

    Time frame: at or before 4 weeks

Sponsors and collaborators

Lead sponsor

BRIM Biotechnology Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2023
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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