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

Neurotrophic Keratitis Clinical Trial

— DEFENDO  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04485546
• Other study ID #: NGF0120
• Status: Completed
• Phase: Phase 4
• Start date: September 9, 2020
• Est. completion date: March 30, 2022

Study information

• Verified date: June 2023
• Source: Dompé Farmaceutici S.p.A
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: March 30, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Keratitis
• Neurotrophic Keratitis

Intervention

Drug:
• cenegermin-bkbj
Cenegermin-bkbj ophthalmic solution administered as one drop in affected eye(s) every 2 hours 6 times daily for 8 weeks

Locations

Country	Name	City	State
United States	Boston	Boston	Massachusetts
United States	Edgewood	Edgewood	Kentucky
United States	Philadelphia	Philadelphia	Pennsylvania
United States	Saint Louis	Saint Louis	Missouri
United States	San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Dompé Farmaceutici S.p.A	Dompé US

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mastropasqua L, Massaro-Giordano G, Nubile M, Sacchetti M. Understanding the Pathogenesis of Neurotrophic Keratitis: The Role of Corneal Nerves. J Cell Physiol. 2017 Apr;232(4):717-724. doi: 10.1002/jcp.25623. Epub 2016 Oct 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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