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

Sponsor
Chonnam National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00442273
Collaborator
(none)
1
Location

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Umbilical cord serum eyedrops
  • Drug: Autologous serum eyedrops
 N/A

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.

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Comparison of Autologous Serum and Umbilical Cord Serum Eyedrops for Dry Eye Syndrome

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 61 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chonnam national university hospital Gwangju Korea, Republic of 501-220

    Sponsors and Collaborators

    • Chonnam National University Hospital

    Investigators

    • Study Director: Kyung chul Yoon, M.D., Chonnam natianl university hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00442273
    Other Study ID Numbers:
    • UCS-0001
    First Posted:
    Mar 1, 2007
    Last Update Posted:
    Mar 1, 2007
    Last Verified:
    Feb 1, 2007
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Syndrome
    Ophthalmic Solutions

    Study Results

    No Results Posted as of Mar 1, 2007