NCT01234623

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2010

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 4, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 26, 2011

Status Verified

April 1, 2011

Enrollment Period

1.2 years

First QC Date

October 12, 2010

Last Update Submit

May 25, 2011

Conditions

Graft vs Host DiseaseSjogren's Disease

Keywords

Umbilical cord serum, eyedrops, GVHD, SS-I, corneal healing

Outcome Measures

Primary Outcomes (1)

  • Corneal epithelial damage evaluated by fluorescein staining (micron meter squares) with digital photos

    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

    28 days treatment

Secondary Outcomes (2)

  • Reduction the patients' painful subjective symptoms

    28 days treatment

  • Reduction the patients' painful subjective symptoms

    15 days treatment

Study Arms (1)

UCB eyedrops, single arm

One-centre pilot study, open, non randomized.

Other: UCS eyedrops

Interventions

UCS eyedropsOTHER

1 ml UCS eyedrops/day topically applied 8 times/day 1 drop/eye for 28 days

Also known as: no brand names, serial or code numbers
UCB eyedrops, single arm

Eligibility Criteria

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

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

You may qualify if:

  • 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.

You may not qualify if:

  • to suffer from glaucoma and being under treatment with antiglaucomatous drugs
  • to have received refractive surgery over the past year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology Unit, Dept.of Specialistic Surgery and Anesthesiological Sciences

Bologna, Bologna, 40138, Italy

Location

Related Publications (3)

  • Buzzi M, Versura P, Vaselli C, Coslovi C, Terzi A, Bontadini A, Campos EC. Fattori di crescita epiteliali nel sangue cordonale. SIES 2008, Bari 24-26 settembre 2008, abstract

    BACKGROUND

  • 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

    RESULT

  • Versura P, Profazio V, Buzzi M, Stancari A, Arpinati M, Malavolta N, Campos EC. Efficacy of standardized and quality-controlled cord blood serum eye drop therapy in the healing of severe corneal epithelial damage in dry eye. Cornea. 2013 Apr;32(4):412-8. doi: 10.1097/ICO.0b013e3182580762.

    PMID: 22955120DERIVED

MeSH Terms

Conditions

Graft vs Host DiseaseSjogren's Syndrome

Condition Hierarchy (Ancestors)

Immune System DiseasesArthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune Diseases

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 12, 2010

First Posted

November 4, 2010

Study Start

February 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 26, 2011

Record last verified: 2011-04

Locations

IT(1)