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Comparison of Autologous Serum and Umbilical Cord Serum Eyedrops for Dry Eye Syndrome

Primary Purpose

Dry Eye Syndrome

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Umbilical cord serum eyedrops
Autologous serum eyedrops
Sponsored by
Chonnam National University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndrome

Eligibility Criteria

20 Years - 61 Years (Adult)All Sexes

Inclusion Criteria:

  • Patients with severe dry eye syndrome who were refractory to conventional treatments and had symptoms of dry eye for more than 3 months
  • Low tear film break-up time (BUT, < 5 sec)
  • Low Schirmer test (5 mm)
  • Positive fluorescein or rose bengal vital staining (≥ 3)

Exclusion Criteria:

  • Active ocular infection or inflammation not associated with dry eye
  • Contact lens wear
  • Ocular allergy
  • Ocular surgery within the recent 3 months
  • Lid or lash abnormalities
  • Pregnant or lactating women

Sites / Locations

  • Chonnam national university hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 28, 2007
Last Updated
February 28, 2007
Sponsor
Chonnam National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00442273
Brief Title
Comparison of Autologous Serum and Umbilical Cord Serum Eyedrops for Dry Eye Syndrome
Official Title
Comparison of Autologous Serum and Umbilical Cord Serum Eyedrops for Dry Eye Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators

Name of the Sponsor
Chonnam National University Hospital

4. Oversight

5. Study Description

Brief Summary
To compare the therapeutic effect between autologous serum and umbilical cord serum eyedrops in the treatment of severe dry eye syndrome.
Detailed Description
Ninety-two eyes of 48 patients with severe dry eye syndrome (34 eyes of 17 patients with Sjögren's syndrome and 58 eyes of 31 patients with non-Sjögren's syndrome) were treated with either 20% autologous serum (41 eyes of 21 patients) or umbilical cord serum eyedrops (51 eyes of 27 patients). Symptom scoring, corneal sensitivity test, tear film break-up time (BUT), Schirmer test, tear clearance rate (TCR), corneal fluorescein staining, and conjunctival impression cytology were performed before and 1 month and 2 months after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Umbilical cord serum eyedrops
Intervention Type
Drug
Intervention Name(s)
Autologous serum eyedrops

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
61 Years
Eligibility Criteria
Inclusion Criteria: Patients with severe dry eye syndrome who were refractory to conventional treatments and had symptoms of dry eye for more than 3 months Low tear film break-up time (BUT, < 5 sec) Low Schirmer test (5 mm) Positive fluorescein or rose bengal vital staining (≥ 3) Exclusion Criteria: Active ocular infection or inflammation not associated with dry eye Contact lens wear Ocular allergy Ocular surgery within the recent 3 months Lid or lash abnormalities Pregnant or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung chul Yoon, M.D.
Organizational Affiliation
Chonnam natianl university hospital
Official's Role
Study Director
Facility Information:
Facility Name
Chonnam national university hospital
City
Gwangju
ZIP/Postal Code
501-220
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Comparison of Autologous Serum and Umbilical Cord Serum Eyedrops for Dry Eye Syndrome

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