Study to Evaluate OXERVATE™ in Patients With Stage 1 Neurotrophic Keratitis

Study Overview
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Brief Summary
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This study is to evaluate the safety and efficacy of OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution in patients with Stage 1 neurotrophic keratitis (NK).

Official Title
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An 8-week, Multicenter, Open Label, Prospective Study With 24 Weeks of Follow-up to Evaluate Safety and Efficacy of OXERVATE™ 0.002% (20 mcg/mL) Cenegermin-bkbj Ophthalmic Solution in Patients With Stage 1 Neurotrophic Keratitis (NK)

Conditions
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Neurotrophic Keratitis

Intervention / Treatment
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* Drug: cenegermin-bkbj


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged ≥ 18 years. Patients with Stage 1 NK defined by the Mackie criteria Exclusion Criteria: Evidence of an active ocular infection (bacterial, viral, protozoal) in either eye. Have current or history of conditions that may confound the study data including but not limited to Ocular Cicatricial Pemphigoid (OCP), Graft Versus Host Disease (GVHD), neuromyelitis optica, uncontrolled dry eye, and Steven Johnson's syndrome. History of severe systemic allergy or severe ocular allergy (including seasonal conjunctivitis expected during the subject's participation in the trial) or chronic conjunctivitis and/or keratitis other than dry eye disease. Patients with severe vision loss with no potential for visual improvement in the study eye, in the opinion of the investigator, or if the subject is deemed legally blind. Ocular surgery or elective ocular surgery expected during participation in the trial. Patients with eyelid abnormality that may alter eyelid function including but not limited to Blepharospasm, Cerebrovascular accident, entropion, ectropion, floppy lid syndrome.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj<br> | Drug: cenegermin-bkbj<br>* Cenegermin-bkbj ophthalmic solution administered as one drop in affected eye(s) every 2 hours 6 times daily for 8 weeks<br>* Other names: OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Epithelial Healing | Percentage of patients who experience corneal epithelial healing. Corneal epithelial healing was defined by the central reading center as the absence of persistent epithelial staining abnormalities related to disease. | Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stage 1 Neurotrophic Keratitis, Corneal Disease, Ocular Disease