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

BRIM Biotechnology

Status and phase: Enrolling; Phase 2

Conditions: Neurotrophic Keratitis

Treatments: Drug: BRM424 Ophthalmic Solution - Dose1; Drug: BRM424 Ophthalmic Solution - Dose2

Study type: Interventional

Funder types: Industry

Identifiers

NCT05927428

BRM424-21-C001

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

BRM424 Ophthalmic Solution - Dose1

Active Comparator group

Treatment:

Drug: BRM424 Ophthalmic Solution - Dose1

BRM424 Ophthalmic Solution - Dose2

Active Comparator group

Treatment:

Drug: BRM424 Ophthalmic Solution - Dose2