Evaluating the effect of Oxervate on neurotrophic ulcers in the eye
Official title: Evaluation of Changes in Corneal Stromal Thickness Using Anterior Segment OCT Following Treatment of Neurotrophic Ulcers With Oxervate
Run by Sight Medical Doctors PLLC · NCT04573647 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Sight Medical Doctors PLLC Academic / other |
| Locations | 1 site (Manhasset, New York) |
| Trial ID | NCT04573647 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with stage 3 neurotrophic ulcers and decreased corneal sensation.
✕Probably not a fit
Patients with impending corneal perforation or those unable to complete diagnostic testing will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While Oxervate has shown efficacy in healing the corneal epithelium, this specific evaluation of its impact on corneal stroma thickness is novel.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Lacripep eye drops for Stage 1 neurotrophic keratitis
This will test whether Lacripep eye drops can improve the corneal surface, vision, corneal sensitivity, and quality of life in adults with Stage 1 neurotrophic keratitis.
-
KB801 versus placebo for healing corneal defects in stage 2 or 3 neurotrophic keratitis
This tests whether KB801 eye drops can safely heal persistent corneal epithelial defects in adults with stage 2 or 3 neurotrophic keratitis.
-
STSP-0902 eye drops for neurotrophic keratitis (Phase II)
This trial will see if STSP-0902 eye drops help adults with Stage 2 or 3 neurotrophic keratitis heal their corneal defects.
-
Using Acthar Gel to treat moderate-severe keratitis in autoimmune patients
This study is testing if Acthar Gel can help people with autoimmune diseases and dry eye feel less eye pain and improve their eye health over 12 weeks.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.