Phase 4
Completed N=37
Study to Evaluate OXERVATE® in Patients With Stage 1 Neurotrophic Keratitis
Neurotrophic Keratitis
Source: ClinicalTrials.gov NCT04485546 ↗
Enrolled (actual)
37
Serious AEs
7.2%
Results posted
Jun 2023
Primary outcomePrimary: Corneal Epithelial Healing — 5; 28 Participants
◆ Published Evidence
Established
▲ Trending
22citations · ~11 / year
Phase IV Multicenter, Prospective, Open-Label Clinical Trial of Cenegermin (rhNGF) for Stage 1 Neurotrophic Keratopathy (DEFENDO).
Summary
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).
Linked Publications
-
Phase IV Multicenter, Prospective, Open-Label Clinical Trial of Cenegermin (rhNGF) for Stage 1 Neurotrophic Keratopathy (DEFENDO).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Corneal Epithelial Healing |
5; 28 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04485546) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.