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

Phase 2

Recruiting

• Conditions: Neurotrophic Keratitis
• Interventions: Drug: BRM424 Ophthalmic Solution - Dose1; Drug: BRM424 Ophthalmic Solution - Dose2

• Registration Number: NCT05927428
• Lead Sponsor: BRIM Biotechnology Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-06-28
• Study First Posted: 2023-07-03
• Study Start: 2024-07-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28
• Primary Completion: 2025-08-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BRM424 Ophthalmic Solution - Dose1	BRM424 Ophthalmic Solution - Dose1	-
BRM424 Ophthalmic Solution - Dose2	BRM424 Ophthalmic Solution - Dose2	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining	at or before 4 weeks

Trial Locations

Locations (1)

Wilmington Eye; 🇺🇸 Leland, North Carolina, United States