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DEFENDO Long Term Follow-up Study in Stage 1 NK Patients
NCT05552261 · View on ClinicalTrials.gov ↗
Study Summary
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
Conditions Studied
Interventions
- DRUG Cenegemin in the DEFENDO Study
Study Locations (4)
California
- New Vision Institute — San Diego
Kentucky
- Cincinnati Eye Institute — Edgewood
Massachusetts
- Tufts Medical Center — Boston
Pennsylvania
- Scheie Eye Institute — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-02-01 |
| Est. Completion | 2024-04-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05552261
The ClinicalTrials.gov registry entry for NCT05552261 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dompé Farmaceutici S.p.A, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Neurotrophic Keratitis appearing as the primary indexed condition, and to 1 intervention — of which Cenegemin in the DEFENDO Study is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05552261 reports 4 study locations spanning 4 distinct geographic areas — top geographies include California, Kentucky, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05552261 about?
NCT05552261 is a clinical study titled "DEFENDO Long Term Follow-up Study in Stage 1 NK Patients". 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® 0.00...
What is the current status of trial NCT05552261?
This trial is currently completed. The enrollment target is 24 participants. The study started on 2023-02-01. Estimated completion is 2024-04-12.
What conditions does trial NCT05552261 study?
This clinical trial studies the following conditions: Neurotrophic Keratitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05552261?
The interventions under investigation include: Cenegemin in the DEFENDO Study (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05552261?
This trial is sponsored by Dompé Farmaceutici S.p.A, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05552261 being conducted?
This trial has 4 study locations across California, Kentucky, Massachusetts, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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