OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate

Status unconfirmed

Conditions studied: Neurotrophic Ulcer, Neurotrophic Keratitis, Neurotrophic Corneal Ulcer, Neurotrophic Keratoconjunctivitis

In brief

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.

Key facts

Study ID

NCT04573647

Run by

Sight Medical Doctors PLLC

People needed

10

Starts

2020-10-01

Expected to finish

2024-12-31

Last updated by the study team

2024-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Neurotrophic keratitis with stage 3 neurotrophic ulcer (stromal thinning)
• Decreased corneal sensation relative to fellow eye determined qualitatively using wisp of cotton-tipped applicator to compare sensation in each eye without anesthesia.

You may not qualify if…

• Impending corneal perforation (descemetocele)
• Unable to physically complete diagnostic testing (cannot position head into slit lamp or OCT)
• Unable to commit to 6 month follow up prior to initiating study
• Unable to self-administer study drug following explanation and demonstration by PI and study coordinator
• Active infectious infiltrate clinically worsening by history or clinical appearance
• Pregnancy; patients must agree to use an acceptable form of birth control during study participation.

Where it is running

• SightMD — Manhasset, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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