Evaluating the effect of Oxervate on neurotrophic ulcers in the eye
Evaluation of Changes in Corneal Stromal Thickness Using Anterior Segment OCT Following Treatment of Neurotrophic Ulcers With Oxervate
This study is testing if Oxervate can help improve the thickness and feeling in the cornea of people with neurotrophic keratitis to prevent future eye ulcers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sight Medical Doctors PLLC Academic / other |
| Locations | 1 site (Manhasset, New York) |
| Trial ID | NCT04573647 on ClinicalTrials.gov |
What this trial studies
This research investigates the impact of Oxervate (cenegermin-bkbj 0.002%), an FDA-approved treatment for neurotrophic corneal ulcers, on the thickness of the corneal stroma in patients with neurotrophic keratitis. The study will utilize optical coherence tomography (OCT) to measure corneal thickness and a Cochet-Bonnet esthesiometer to assess corneal sensation during and after treatment. By determining whether Oxervate increases corneal thickness and sensation, the study aims to reduce the risk of future ulcer formation. Approximately 10 subjects will participate in this observational study.
Who should consider this trial
Good fit: Ideal candidates include individuals with stage 3 neurotrophic ulcers and decreased corneal sensation.
Not a fit: Patients with impending corneal perforation or those unable to complete diagnostic testing will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes for patients with neurotrophic ulcers by enhancing corneal thickness and sensation.
How similar studies have performed: While Oxervate has shown efficacy in healing the corneal epithelium, this specific evaluation of its impact on corneal stroma thickness is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 this trial is running
Manhasset, New York
- SightMD — Manhasset, New York, United States (Recruiting)
Study contacts
- Principal investigator: Brad Kligman, MD — Sight Medical Doctors PLLC
- Study coordinator: Brad Kligman, MD
- Email: bkligman@sightmd.com
- Phone: 516-627-0033
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.