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Completed No phase listed Observational Results available

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

ClinicalTrials.gov ID: NCT05552261

Public ClinicalTrials.gov record NCT05552261. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 9:18 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Long-term Extension Study to Evaluate the Safety and Efficacy of OXERVATE® 0.002% (20 mcg/mL) Cenegermin-bkbj Ophthalmic Solution in Patients With Stage 1 Neurotrophic Keratitis Who Enrolled in the DEFENDO Study (NGF0120)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT05552261
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Dompé Farmaceutici S.p.A
Industry
Enrollment
24 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 1, 2023 (Actual)
Primary completion
Apr 12, 2024 (Actual)
Completion
Apr 12, 2024 (Actual)
Last update posted
Nov 28, 2025

2023 – 2024

United States locations

U.S. sites
4
U.S. states
4
U.S. cities
4
Facility City State ZIP Site status
New Vision Institute San Diego California 92037 —
Cincinnati Eye Institute Edgewood Kentucky 41017 —
Tufts Medical Center Boston Massachusetts 02011 —
Scheie Eye Institute Philadelphia Pennsylvania 19104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05552261, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 28, 2025 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05552261 live on ClinicalTrials.gov.

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