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

NCT ID: NCT05927428

Last Updated: 2024-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2025-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Neurotrophic Keratitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open-label, Randomized Study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BRM424 Ophthalmic Solution - Dose1

Group Type ACTIVE_COMPARATOR

BRM424 Ophthalmic Solution - Dose1

Intervention Type DRUG

A topical drop of BRM424 ophthalmic solution.

BRM424 Ophthalmic Solution - Dose2

Group Type ACTIVE_COMPARATOR

BRM424 Ophthalmic Solution - Dose2

Intervention Type DRUG

A topical drop of BRM424 ophthalmic solution.

Interventions

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BRM424 Ophthalmic Solution - Dose1

A topical drop of BRM424 ophthalmic solution.

Intervention Type DRUG

BRM424 Ophthalmic Solution - Dose2

A topical drop of BRM424 ophthalmic solution.

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BRIM Biotechnology Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Wilmington Eye

Leland, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Crystal Wong

Role: primary

910-763-3601

Other Identifiers

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BRM424-21-C001

Identifier Type: -

Identifier Source: org_study_id

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