Cord Blood Serum in the Treatment of Ocular Surface Diseases
This study has been completed.
Sponsor:
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
- are effective in the healing of corneal epithelial defects.
- 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
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
No publications provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
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 Immune System Diseases Arthritis, Rheumatoid Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Xerostomia Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases Dry Eye Syndromes Lacrimal Apparatus Diseases |
Eye Diseases Connective Tissue Diseases Autoimmune Diseases Tetrahydrozoline Nasal Decongestants Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013