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

Completed · Phase 4

Conditions studied: Neurotrophic Keratitis

In brief

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).

Key facts

Study ID

NCT04485546

Run by

Dompé Farmaceutici S.p.A

People needed

37

Starts

2020-09-09

Expected to finish

2022-03-30

Last updated by the study team

2025-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• San Diego — San Diego, California, United States
• Edgewood — Edgewood, Kentucky, United States
• Boston — Boston, Massachusetts, United States
• Saint Louis — St Louis, Missouri, United States
• Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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