Study to Evaluate OXERVATE® in Patients With Stage 1 Neurotrophic Keratitis (DEFENDO)

Dompé

Status and phase: Completed; Phase 4

Conditions: Neurotrophic Keratitis

Treatments: Drug: cenegermin-bkbj

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04485546

NGF0120

Details and patient eligibility

About

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).

Full description

This is a 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)

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female aged ≥ 18 years.
2. Patients with Stage 1 NK defined by the Mackie criteria

Exclusion criteria

1. Evidence of an active ocular infection (bacterial, viral, protozoal) in either eye.
2. 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.
3. 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.
4. 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.
5. Ocular surgery or elective ocular surgery expected during participation in the trial.
6. Patients with eyelid abnormality that may alter eyelid function including but not limited to Blepharospasm, Cerebrovascular accident, entropion, ectropion, floppy lid syndrome.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj

Experimental group

Description:

cenegermin-bkbj ophtalmic solution administered as one drop in affected eye(s) every 2 hours 6 times daily for 8 weeks

Treatment:

Drug: cenegermin-bkbj