ClinicalTrials.gov
ClinicalTrials.gov Menu

The Evaluation of Thiol Redox Status in Conjunctiva of Dry Eye Patients

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.
ClinicalTrials.gov Identifier: NCT00718926
Recruitment Status : Unknown
Verified May 2008 by Meiji University of Oriental Medicine.
Recruitment status was:  Not yet recruiting
First Posted : July 21, 2008
Last Update Posted : July 21, 2008
Sponsor:
Collaborator:
Kyoto Prefectural University of Medicine
Information provided by:
Meiji University of Oriental Medicine

Brief Summary:
Dry eye disease is related with oxidative stress at the ocular surface. GSH is one of the key factor of protect from oxidative stress. To evaluate thiol status of ocular surface cells by monitoring GSH concentration, we can evaluate the severity of dry eye.

Condition or disease
Dry Eye Disease

Detailed Description:
The conjunctival cells are collected by impression cytology. Those cells are stained with 100 mM of monochlorobimane (MCB, M-1381, Molecular Probes, Eugene, OR) and propidium iodide (PI). Fluorescent intensity, reflecting the amount of icGSH, was inspected under a confocal laser scan microscope. To detect the GSH levels we used a fluorescent MCB probe with excitation and emission wavelengths of 405 nm and 410-480 nm, respectively. The cell-permeating MCB probe is non-fluorescent but forms a fluorescent adduct with GSH in a reaction catalyzed by glutathione-S-transferase.

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case Control
Official Title: The Evaluation of Thiol Redox Status in Conjunctiva of Dry Eye Patients
Study Start Date : August 2008
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Sjogren
Sjogren syndrome with dry eye
non-Sjogren
dry eye without Sjogren syndrome
Short-BUT
Dry eye by shortened tear break up time
control
normal patients



Primary Outcome Measures :
  1. Tear amount, tear break up time, and so on are measured clinically. The thiol redox status is measured by staining the membrane. [ Time Frame: Once a month (totally 2-4 times) at the clinic ]

Biospecimen Retention:   Samples Without DNA
After application of anethesia eyedrops, nitrocel membrane is put ocular surface. Then, removed the membrane. This method is commonly used clinically.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The dry eye patients at the clinic of Kyoto Prefectural University of Medicine hospital
Criteria

Inclusion Criteria:

  • dry eye patients
  • control volunteers

Exclusion Criteria:

  • Young (less than 20) patients
  • The patients who rejected this study

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): NCT00718926


Contacts
Contact: Jun Yamada, MD, PhD. +81-75-251-5663 jyamada@koto.kpu-m.ac.jp
Contact: Norihiko Yokoi, MD, PhD. +81-75-251-5663 nyokoi@koto.kpu-m.ac.jp

Locations
Japan
Kyoto Prefectural University of Medicine hospital Recruiting
Kyoto, Japan
Contact: Shigeru Kinoshita, MD, PhD.    +81-75-251-5577    shigeruk@koto.kpu-m.ac.jp   
Sponsors and Collaborators
Meiji University of Oriental Medicine
Kyoto Prefectural University of Medicine

Responsible Party: Jun Yamada MD. PhD., Meiji University of Oriental Medicine
ClinicalTrials.gov Identifier: NCT00718926     History of Changes
Other Study ID Numbers: C244
First Posted: July 21, 2008    Key Record Dates
Last Update Posted: July 21, 2008
Last Verified: May 2008

Keywords provided by Meiji University of Oriental Medicine:
dry eye
Thiol redox
Oxidative stress

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