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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00442273
First Posted: March 1, 2007
Last Update Posted: March 1, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Chonnam National University Hospital
  Purpose
To compare the therapeutic effect between autologous serum and umbilical cord serum eyedrops in the treatment of severe dry eye syndrome.

Condition Intervention
Dry Eye Syndrome Drug: Umbilical cord serum eyedrops Drug: Autologous serum eyedrops

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Chonnam National University Hospital:

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.
  Eligibility

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Ages Eligible for Study:   20 Years to 61 Years   (Adult)
Sexes Eligible for Study:   All
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00442273


Locations
Korea, Republic of
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
  More Information

ClinicalTrials.gov Identifier: NCT00442273     History of Changes
Other Study ID Numbers: UCS-0001
First Submitted: February 28, 2007
First Posted: March 1, 2007
Last Update Posted: March 1, 2007
Last Verified: February 2007

Additional relevant MeSH terms:
Syndrome
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Tetrahydrozoline
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents