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

An Open-Label, Multi-Center, Phase 2 Dose Ranging Study of BRM424 Ophthalmic Solution in Patients With Neurotrophic Keratitis (NK)

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.

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;