NCT04573647

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

3.7 years

First QC Date

September 28, 2020

Last Update Submit

April 16, 2024

Conditions

Neurotrophic UlcerNeurotrophic KeratitisNeurotrophic Corneal UlcerNeurotrophic Keratoconjunctivitis

Keywords

Neurotrophic UlcerNeurotrophic KeratoconjunctivitisOptical Coherence TomographyOCT

Outcome Measures

Primary Outcomes (1)

  • Stromal Thickness

    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.

    6 Months

Secondary Outcomes (2)

  • Esthesiometry

    6 Months

  • Clinical resolution of epithelial defects

    6 Months

Study Arms (1)

Treatment group

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]

Interventions

Cenegermin-Bkbj 0.002% Ophthalmic Solution [OXERVATE]DRUG

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.

Treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with stage 3 neurotrophic keratitis (ulcer)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SightMD

Manhasset, New York, 11030, United States

RECRUITING

Related Publications (2)

  • Sheha H, Tighe S, Hashem O, Hayashida Y. Update On Cenegermin Eye Drops In The Treatment Of Neurotrophic Keratitis. Clin Ophthalmol. 2019 Oct 7;13:1973-1980. doi: 10.2147/OPTH.S185184. eCollection 2019.

    PMID: 31631965BACKGROUND

  • Micera A, Lambiase A, Puxeddu I, Aloe L, Stampachiacchiere B, Levi-Schaffer F, Bonini S, Bonini S. Nerve growth factor effect on human primary fibroblastic-keratocytes: possible mechanism during corneal healing. Exp Eye Res. 2006 Oct;83(4):747-57. doi: 10.1016/j.exer.2006.03.010. Epub 2006 May 23.

    PMID: 16716299BACKGROUND

MeSH Terms

Interventions

cenegerminOphthalmic Solutions

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Brad Kligman, MD

    Sight Medical Doctors PLLC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brad Kligman, MD

CONTACT

516-627-0033bkligman@sightmd.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 5, 2020

Study Start

October 1, 2020

Primary Completion

June 30, 2024

Study Completion

December 31, 2024

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)