DEFENDO Long Term Follow-up Study in Stage 1 NK Patients

Completed

Conditions studied: Neurotrophic Keratitis

In brief

Primary Objective To evaluate the long-term safety and efficacy (healing) of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution in Stage 1 neurotrophic keratitis (NK) patients who enrolled in the DEFENDO study. Secondary Objective To evaluate the long-term efficacy of OXERVATE® 0.002% (20 mcg/mL) cenergemin-bkbj ophthalmic solution in terms of corneal sensitivity, Schirmer I test, tear film break-up time (TFBUT), best corrected distance visual acuity (BCDVA), and quality of life at 24 and 30 months post-treatment

Key facts

Study ID

NCT05552261

Run by

Dompé Farmaceutici S.p.A

People needed

24

Starts

2023-02-01

Expected to finish

2024-04-12

Last updated by the study team

2025-11-28

Who can join

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

You may qualify if…

• Previously enrolled in the DEFENDO Study.
• Satisfied all Informed Consent requirements. The patient and/or their legal representative read, signed, and dated the IRB approved Informed Consent document before any study-related procedures were performed.
• Had the ability and willingness to comply with study procedures.

You may not qualify if…

• Were participating in another study that involved treating the study eye. Participation in non-ocular studies was acceptable provided that the treatment was not considered to be confounding with the DEFENDO Long-Term Follow-up Study, in the opinion of the Investigator.

Where it is running

• New Vision Institute — San Diego, California, United States
• Cincinnati Eye Institute — Edgewood, Kentucky, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Scheie Eye Institute — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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