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NCT04573647 · ClinicalTrials.gov registry record
OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate
A clinical trial of Neurotrophic Keratitis and Neurotrophic Ulcer, sponsored by Sight Medical Doctors P.
- Recruiting
- Registry status
- 10
- Enrollment target
- 1
- Study location
NCT04573647: Recruiting study of Neurotrophic Keratitis and Neurotrophic Ulcer, sponsored by Sight Medical Doctors P.
NCT04573647 is a study of Neurotrophic Keratitis and Neurotrophic Ulcer that is actively recruiting participants, run by Sight Medical Doctors P. The registered enrollment target is 10 participants, below the 22-participant average among 6 other Neurotrophic Keratitis trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04573647, a study of Neurotrophic Keratitis and Neurotrophic Ulcer, is actively recruiting participants, sponsored by Sight Medical Doctors P.
- RECRUITING
- Registry status
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Neurotrophic keratitis (NK) is a condition where the cornea, or clear outer covering of the eye, has reduced sensation due to a variety of reasons. In more advanced cases of NK, the cornea can develop an area of thinning called an ulcer. The purpose of this research is to find out if Oxervate (cenegermin-bkbj 0.002%) an FDA-approved treatment for neurotrophic corneal ulcers leads to an increase in thickness of the corneal stroma (middle layer of the cornea) during and after treatment of a neurotrophic ulcer. Corneal thickness will be measured using optical coherence tomography (OCT), a non-contact imaging device used routinely in ophthalmology examinations. Corneal sensation will also be measured during and after treatment with a device called a Cochet-Bonnet esthesiometer to see if the treatment increases corneal sensation.
Conditions Studied
Interventions
- DRUG Cenegermin-Bkbj 0.002% Ophthalmic Solution [OXERVATE]
Study Locations (1)
New York
- SightMD - Manhasset
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2020-10-01 |
| Est. Completion | 2024-12-31 |
What NCT04573647 shows while recruiting
NCT04573647 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 22-participant average among 6 other Neurotrophic Keratitis trials with a reported enrollment target (55% lower).
The record links to 4 conditions, with Neurotrophic Keratitis appearing as the primary indexed condition, and to 1 intervention - of which Cenegermin-Bkbj 0.002% Ophthalmic Solution [OXERVATE] is the first listed.
NCT04573647 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04573647 about?
NCT04573647 is a clinical study titled "OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate". Neurotrophic keratitis (NK) is a condition where the cornea, or clear outer covering of the eye, has reduced sensation due to a variety of reasons. In more advanced cases of NK, the cornea can develop an area of thinning called an ulcer. The purpose of this research is to find out if Oxervate (ceneg...
What is the current status of trial NCT04573647?
This trial is currently recruiting. The enrollment target is 10 participants. The study started on 2020-10-01. Estimated completion is 2024-12-31.
What conditions does trial NCT04573647 study?
This clinical trial studies the following conditions: Neurotrophic Keratitis, Neurotrophic Ulcer, Neurotrophic Corneal Ulcer, Neurotrophic Keratoconjunctivitis.
What interventions are being tested in trial NCT04573647?
The interventions under investigation include: Cenegermin-Bkbj 0.002% Ophthalmic Solution [OXERVATE] (DRUG).
Who is sponsoring clinical trial NCT04573647?
This trial is sponsored by Sight Medical Doctors P, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04573647 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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