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

Sponsor

BRIM Biotechnology Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05927428

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The objective of this study is to compare the safety and efficacy of BRM424 OS compared to vehicle in patients with neurotrophic keratitis.

Condition or Disease	Intervention/Treatment	Phase
Neurotrophic Keratitis	Drug: BRM424 Ophthalmic Solution Drug: Vehicle	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double MaskingDouble Masking

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Double-Masked, Multi-Center, Randomized, Vehicle- Controlled, Phase II Trial of the Efficacy and Safety of BRM424 Ophthalmic Solution in Patients With Neurotrophic Keratitis (NK)

Anticipated Study Start Date :

Sep 30, 2023

Anticipated Primary Completion Date :

Jan 30, 2025

Anticipated Study Completion Date :

May 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: BRM424 Ophthalmic Solution	Drug: BRM424 Ophthalmic Solution A topical drop of BRM424 ophthalmic solution.
Placebo Comparator: Vehicle	Drug: Vehicle A topical drop of vehicle (minus active) ophthalmic solution.

Arm

Intervention/Treatment

Active Comparator: BRM424 Ophthalmic Solution

Drug: BRM424 Ophthalmic Solution

A topical drop of BRM424 ophthalmic solution.

Placebo Comparator: Vehicle

Drug: Vehicle

A topical drop of vehicle (minus active) ophthalmic solution.

Outcome Measures

Primary Outcome Measures

Percentage of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

BRIM Biotechnology Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

BRIM Biotechnology Inc.

ClinicalTrials.gov Identifier:

NCT05927428

Other Study ID Numbers:

BRM424-21-C001

First Posted:

Jul 3, 2023

Last Update Posted:

Jul 3, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Keratitis

Ophthalmic Solutions

Study Results

No Results Posted as of Jul 3, 2023