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NCT05552261 · ClinicalTrials.gov registry record
DEFENDO Long Term Follow-up Study in Stage 1 NK Patients
A clinical trial of Neurotrophic Keratitis, sponsored by Dompé Farmaceutici S.p.A.
- Completed
- Registry status
- 24
- Enrollment target
- 4
- Study locations
NCT05552261: Completed study of Neurotrophic Keratitis, sponsored by Dompé Farmaceutici S.p.A.
NCT05552261 is a study of Neurotrophic Keratitis that has completed, run by Dompé Farmaceutici S.p.A. The registered enrollment target is 24 participants, above the 20-participant average among 6 other Neurotrophic Keratitis trials with a reported enrollment target (20% higher). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05552261, a study of Neurotrophic Keratitis, has completed, sponsored by Dompé Farmaceutici S.p.A.
- COMPLETED
- Registry status
- 24 participants
- Enrollment target
- 4
- Study locations
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
Primary Outcome
Corneal epithelial at Month 24 and Month 30 of the NGF0122 study was summarized as a binary goal attainment variable (Yes/No) based on the subset of patients who achieved corneal epithelial healing at Week 8 of the NGF0120, as determined by the Central Reading Center (CRC). Healing was defined as the absence of persistent epithelial staining abnormalities related to disease. The persistence (or worsening) of a staining pattern in the same corneal area was considered a failure in terms of heali
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 |
What the finished NCT05552261 record still lists
NCT05552261 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 24 participants, a relatively small participant target, above the 20-participant average among 6 other Neurotrophic Keratitis trials with a reported enrollment target (20% higher).
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.
NCT05552261 reports a single indexed study location in California, Kentucky, Massachusetts.
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.
What interventions are being tested in trial NCT05552261?
The interventions under investigation include: Cenegemin in the DEFENDO Study (DRUG).
Who is sponsoring clinical trial NCT05552261?
This trial is sponsored by Dompé Farmaceutici S.p.A, which has 27 total clinical trials registered on ClinicalTrials.gov.
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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