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

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

Treatments tested in this trial

  • BRM424 Ophthalmic Solution - Dose1
  • BRM424 Ophthalmic Solution - Dose2

Treatment groups

12 Participants
are divided into 2 treatment groups

Sponsors and collaborators