Cord Blood Serum in the Treatment of Ocular Surface Diseases

This study has been completed.
Sponsor:
Information provided by:
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier:
NCT01234623
First received: October 12, 2010
Last updated: May 25, 2011
Last verified: April 2011
  Purpose

Human autologous serum (AS) eye drops have been successfully used in the treatment of severe ocular surface disorders and the enhancement of corneal wound healing, due to their growth factor (GF) content. Umbilical cord serum (UCS) contains even higher GF concentrations and the objective of the study was to prove whether UCS eye drops

  1. are effective in the healing of corneal epithelial defects.
  2. ameliorate the painful subjective symptoms

Condition Intervention Phase
Graft vs Host Disease
Sjogren's Disease
Other: UCS eyedrops
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Phase. Cord Blood Serum in the Treatment of Ocular Surface Diseases

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:

Primary Outcome Measures:
  • Corneal epithelial damage evaluated by fluorescein staining (micron meter squares) with digital photos [ Time Frame: 28 days treatment ] [ Designated as safety issue: Yes ]
    Digital photographs taken at the slit lamp will be evaluated by means of an Image Analyzer softare, to determine the area of corneal epithelial damage involved at a given stand point. Reduction of damaged area will be estimated in micron meter squares


Secondary Outcome Measures:
  • Reduction the patients' painful subjective symptoms [ Time Frame: 28 days treatment ] [ Designated as safety issue: Yes ]
    Subjective symptoms will be evaluated by means of a validated Questionnaire (OSDI, Ocular Surface Disease Index) at the given stand points

  • Reduction the patients' painful subjective symptoms [ Time Frame: 15 days treatment ] [ Designated as safety issue: Yes ]
    Subjective symptoms will be evaluated by means of a validated Questionnaire (OSDI, Ocular Surface Disease Index) at the given stand points


Estimated Enrollment: 30
Study Start Date: February 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
UCB eyedrops, single arm
One-centre pilot study, open, non randomized.
Other: UCS eyedrops
1 ml UCS eyedrops/day topically applied 8 times/day 1 drop/eye for 28 days
Other Name: no brand names, serial or code numbers

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult outpatients suffering from ocular surface discomfort and recurrent or permanent corneal epithelial defects

Criteria

Inclusion Criteria:

  • to suffer from GVHD after bone marrow transplantation or SS-I
  • presence of permanent or transient corneal epithelial defects scored > 2 , according to DEWS severity classification
  • to be in a general healthy condition
  • signature of study consent for participation and personal data treatment.

Exclusion Criteria:

  • to suffer from glaucoma and being under treatment with antiglaucomatous drugs
  • to have received refractive surgery over the past year
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01234623

Locations
Italy
Ophthalmology Unit, Dept.of Specialistic Surgery and Anesthesiological Sciences
Bologna, Italy, 40138
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Investigators
Study Director: Emilio C Campos, MD Head of Ophthalmology Unit, Dept.of Specialistic Surgery and Anesthesiological Sciences, University of Bologna, Policlinico S. Orsola-Malpighi, Pad 1 Palagi, Via Palagi 9 -40138 Bologna Italy
  More Information

Publications:
P. Versura, V. Profazio, L. Foroni, M. Buzzi, A. Stancari, EC Campos. Cord blood serum eye drops in the treatment of ocular surface diseases in GVHD patients. A pilot study. 6th International Conference on the Tear Film & Ocular Surface: Basic Science and Clinical Relevance, Florence , September 22-25, 2010 Abstract

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Emilio C Campos, Head. Ophthalmology Unit
ClinicalTrials.gov Identifier: NCT01234623     History of Changes
Other Study ID Numbers: EudraCT: 2008-005757-38
Study First Received: October 12, 2010
Last Updated: May 25, 2011
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
Umbilical cord serum, eyedrops, GVHD, SS-I, corneal healing

Additional relevant MeSH terms:
Graft vs Host Disease
Sjogren's Syndrome
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Dry Eye Syndromes
Eye Diseases
Immune System Diseases
Joint Diseases
Lacrimal Apparatus Diseases
Mouth Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Stomatognathic Diseases
Xerostomia
Ophthalmic Solutions
Tetrahydrozoline
Autonomic Agents
Cardiovascular Agents
Nasal Decongestants
Peripheral Nervous System Agents
Pharmaceutical Solutions
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on October 20, 2014