Phase 4 N=37 Treatment

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

Neurotrophic Keratitis

Bottom Line

View on ClinicalTrials.gov: NCT04485546 ↗

Enrolled (actual)

Serious AEs

7.2%

Results posted

Jun 2023

Primary outcome: Primary: Corneal Epithelial Healing — 5; 28 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: cenegermin-bkbj (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Dompé Farmaceutici S.p.A
Primary completion: Sep 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Corneal Epithelial Healing	5; 28	—

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).

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04485546). 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.