OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04573647|
Recruitment Status : Not yet recruiting
First Posted : October 5, 2020
Last Update Posted : October 5, 2020
|Condition or disease||Intervention/treatment|
|Neurotrophic Ulcer Neurotrophic Keratitis Neurotrophic Corneal Ulcer Neurotrophic Keratoconjunctivitis||Drug: Cenegermin-Bkbj 0.002% Ophthalmic Solution [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 such as previous surgery or infection. In more advanced cases of NK, the cornea can develop an area of thinning called an ulcer. If the cornea becomes too thin, it is at risk for perforation or rupture, which requires extensive surgery to save vision and the eye. This risk can last for many years even after the ulcer is no longer active. 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. The FDA trials demonstrated that Oxervate does lead to more rapid healing of the epithelium (thin surface layer) of the cornea, but we are still unsure if it increases the thickness of the stroma, which is the strongest part of the cornea. 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. If treatment with Oxervate increases corneal sensation, then this decreases the risk of future ulcer formation.
About 10 subjects will take part in this research.
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||Evaluation of Changes in Corneal Stromal Thickness Using Anterior Segment OCT Following Treatment of Neurotrophic Ulcers With Oxervate|
|Estimated Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||January 31, 2022|
|Estimated Study Completion Date :||January 31, 2022|
All participants in this trial will be in the treatment group. They will administer Oxervate following the FDA approved guidelines: 1 drop to the affected eye 6 times per day for 8 weeks.
Drug: Cenegermin-Bkbj 0.002% Ophthalmic Solution [OXERVATE]
Research subjects will use oxervate in affected eye following approved treatment regimen and have their eye measured with optical coherence tomography and a Cochet-Bonnet esthesiometer at various time points before, during and after treatment.
- Stromal Thickness [ Time Frame: 6 Months ]To determine with optical coherence tomography if stromal thickness at the thinnest point of a neurotrophic ulcer increases during and after treatment with Oxervate independent of corneal epithelium.
- Esthesiometry [ Time Frame: 6 Months ]To quantitatively measure change in corneal esthesiometry during and after treatment of neurotrophic ulcers with Oxervate using Cochet-Bonnet esthesiometry
- Clinical resolution of epithelial defects [ Time Frame: 6 Months ]To evaluate time course of clinical resolution of epithelial defects in neurotrophic ulcers subjectively determined by slit lamp examination
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04573647
|Contact: Brad Kligman, MDfirstname.lastname@example.org|
|Principal Investigator:||Brad Kligman, MD||Sight Medical Doctors PLLC|