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OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate

NCT04573647 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2024-04-17

No results posted yet for this 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

Interventions

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.

Sponsors & Collaborators

  • Dompé, US, Inc.

    collaborator UNKNOWN

  • Sight Medical Doctors PLLC

    lead OTHER

Principal Investigators

  • Brad Kligman, MD · Sight Medical Doctors PLLC

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2024-06-30
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04573647 on ClinicalTrials.gov