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

This study has been completed.

First Received: February 28, 2007 No Changes Posted

Sponsored by:	Chonnam National University Hospital
Information provided by:	Chonnam National University Hospital
ClinicalTrials.gov Identifier:	NCT00442273

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

Drug Information available for: Tetrahydrozoline Tetrahydrozoline hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Autologous Serum and Umbilical Cord Serum Eyedrops for Dry Eye Syndrome

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

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

Study placed in the following topic categories:

Pseudoephedrine
Oxymetazoline
Phenylephrine
Eye Diseases
Vasoconstrictor Agents
Lacrimal Apparatus Diseases

Ephedrine
Dry Eye Syndromes
Cardiovascular Agents
Peripheral Nervous System Agents
Tetrahydrozoline
Nasal Decongestants

Additional relevant MeSH terms:

Respiratory System Agents
Disease
Sympathomimetics
Eye Diseases
Physiological Effects of Drugs
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Cardiovascular Agents
Tetrahydrozoline

Pharmacologic Actions
Nasal Decongestants
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Syndrome
Vasoconstrictor Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009