Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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
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 |
Interested in This Trial?
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, categorized as an unspecified phase. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 20-participant average among 6 other Neurotrophic Keratitis trials with a reported enrollment target (20% higher). The listed sponsor is Dompé Farmaceutici S.p.A, which has 27 total studies on file at ClinicalTrials.gov.
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 4 study locations spanning 4 distinct geographic areas - top geographies include 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.
Learn More About Clinical Trials
Similar trials for Neurotrophic Keratitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study Comparing KB801 Verse Placebo in Patients With Stage 2 or 3 Neurotrophic Keratitis
RECRUITING · Phase 1
-
Assessment of the Initial Efficacy and Safety of BRM424 Ophthalmic Solutions in Patients With Neurotrophic Keratitis
RECRUITING · Phase 2
-
OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate
RECRUITING
-
Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease
RECRUITING · Phase 4
-
DOMPE -MT Neurotrophic Keratitis
ACTIVE NOT RECRUITING · Phase 4
-
Corneal Nerves After Treatment With Cenegermin
COMPLETED
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.