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

This study has been completed.
Sponsor:
Information provided by:
Chonnam National University Hospital
ClinicalTrials.gov Identifier:
NCT00442273
First received: February 28, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Comparison of Autologous Serum and Umbilical Cord Serum Eyedrops for Dry Eye Syndrome

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   20 Years to 61 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00442273     History of Changes
Other Study ID Numbers: UCS-0001
Study First Received: February 28, 2007
Last Updated: February 28, 2007
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal 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 16, 2013