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NCT04627571 · ClinicalTrials.gov registry record
Corneal Nerves After Treatment With Cenegermin
A clinical trial of Neurotrophic Keratitis, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- 8
- Enrollment target
- 1
- Study location
NCT04627571: Completed study of Neurotrophic Keratitis, sponsored by University of California, Los Angeles.
NCT04627571 is a study of Neurotrophic Keratitis that has completed, run by University of California, Los Angeles. The registered enrollment target is 8 participants, below the 23-participant average among 6 other Neurotrophic Keratitis trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04627571, a study of Neurotrophic Keratitis, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
Neurotrophic keratopathy (NK) is a condition in which patients have fewer or complete absence of nerves in the cornea, characterized by the reduced or absent corneal sensation. The lack of nerves in the cornea also result in damages of the cornea and in severe situation the loss of the eye. Cenegermin (trade name Oxervate) is a nerve growth factor eye drops designed to treat NK, and currently, it is the only FDA-approved medication for this purpose. Even though cenegermin is effective in the majority of patients, there is a lack of understanding of how cenegermin works in the eye. In this study, investigators aim to determine the structural and functional effects of cenegermin on the cornea, using non-invasive technologies including in vivo confocal microscopy on study participants with NK over the course of a year.
Primary Outcome
To determine the changes in corneal nerve fiber density (CNFD), assessed by in vivo confocal microscopy.
Conditions Studied
Interventions
- DRUG Cenegermin Ophthalmic Solution [Oxervate]
Study Locations (1)
California
- University of California, Los Angeles - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2022-05-23 |
| Est. Completion | 2025-03-25 |
What the finished NCT04627571 record still lists
NCT04627571 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 23-participant average among 6 other Neurotrophic Keratitis trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Neurotrophic Keratitis appearing as the primary indexed condition, and to 1 intervention - of which Cenegermin Ophthalmic Solution [Oxervate] is the first listed.
NCT04627571 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04627571 about?
NCT04627571 is a clinical study titled "Corneal Nerves After Treatment With Cenegermin". Neurotrophic keratopathy (NK) is a condition in which patients have fewer or complete absence of nerves in the cornea, characterized by the reduced or absent corneal sensation. The lack of nerves in the cornea also result in damages of the cornea and in severe situation the loss of the eye. Ceneger...
What is the current status of trial NCT04627571?
This trial is currently completed. The enrollment target is 8 participants. The study started on 2022-05-23. Estimated completion is 2025-03-25.
What conditions does trial NCT04627571 study?
This clinical trial studies the following conditions: Neurotrophic Keratitis.
What interventions are being tested in trial NCT04627571?
The interventions under investigation include: Cenegermin Ophthalmic Solution [Oxervate] (DRUG).
Who is sponsoring clinical trial NCT04627571?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04627571 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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