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Blood Based Eyedrops From Different Sources in the Treatment of Severe Keratopathy

NCT03064984 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-02-27

No results posted yet for this study

Summary

Topical preparations (eye drops) derived from the blood have become a relatively common treatment for more advanced forms of keratopathy. The purpose of this study is to evaluate the effect of two blood components from donors (serum cord blood and serum from adult subject donor peripheral blood) in the treatment of severe keratopathies.

Conditions

  • Keratopathy
  • Sjogren's Syndrome
  • GVHD - Graft-Versus-Host Disease

Interventions

OTHER

CBS eyedrops

CBS eyedrops (prepared from umbilical cord blood serum) will be provided as frozen vials containing 0.8 ml of the product and will be administered at a regimen of 1 drop / 8 times day / each eye during the waking period, with the last administration to take before bedtime.

OTHER

PBS eyedrops

PBS eyedrops (prepared from adult peripheral blood serum) will be provided as frozen vials containing 0.8 ml of the product and will be administered at a regimen of 1 drop / 8 times day / each eye during the waking period, with the last administration to take before bedtime.

Sponsors & Collaborators

  • University of Bologna

    collaborator OTHER

  • Regione Emilia-Romagna

    collaborator OTHER

  • Centro Nazionale Sangue

    collaborator OTHER_GOV

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Emilio C Campos, MD · AOU Bologna, University of Bologna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-30
Primary Completion
2017-06-30
Completion
2017-09-30

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 NCT03064984 on ClinicalTrials.gov