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An 8-week Follow-up to Evaluate the Renewal of Corneal Nerves Structure and Function in Patients With Neurotrophic Keratopathy Treated With Recombinant Human Nerve Growth Factor (rhNGF) Eyedrops

NCT04293549 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2020-03-05

No results posted yet for this study

Summary

A prospective, longitudinal, cross-sectional, observational Study with a 8-week Follow-up to evaluate the renewal of corneal nerves structure and function in patients with Neurotrophic Keratopathy treated with recombinant human Nerve Growth Factor (rhNGF) eyedrops.

Conditions

  • Neurotrophic Keratopathy

Interventions

DRUG

Cenegermin, recombinant human Nerve Growth Factor (rhNGF) eyedrops

rhNGF 20µg/ml (Cenegermin) eyedrops, 1 drop every 2 hours (6 times a day) for 8 weeks. Patients underwent clinical examination with corneal fluorescein staining, Schirmer I tear test, assessment of corneal sensitivity with Cochet-Bonnet aesthesiometer and morphological examination of the nerves by In Vivo Confocal Microscopy (IVCM) at baseline and after 4 and 8 weeks of treatment

Sponsors & Collaborators

  • G. d'Annunzio University

    lead OTHER

Principal Investigators

  • Leonardo Mastropasqua, Professor · Ophtalmology Clinic, G. d'Annunzio University

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2018-11-30
Completion
2018-11-30
FDA Drug
Yes

Countries

  • Italy

Study Locations

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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 NCT04293549 on ClinicalTrials.gov