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

ConditionNeurotrophic Keratitis

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorBRIM Biotechnology Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be at least 18 years of age;

Provide written informed consent;

Patients with NK Stage 2 (PED) or Stage 3 (corneal ulcer);

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

BRM424 Ophthalmic Solution - Dose1
Drug
A topical drop of BRM424 ophthalmic solution.
BRM424 Ophthalmic Solution - Dose2
Drug
A topical drop of BRM424 ophthalmic solution.

Treatment groups

12 Participants

are divided into 2 treatment groups

Group A: BRM424 Ophthalmic Solution - Dose1Active comparator 1 intervention

Group B: BRM424 Ophthalmic Solution - Dose2Active comparator 1 intervention

Trial outcomes

Primary outcomes

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 contacts

Click on the lead sponsor to view all of their trials.

BRIM Biotechnology Inc.

Lead sponsor

Source ClinicalTrials.gov

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