The Evaluation of Thiol Redox Status in Conjunctiva of Dry Eye Patients - Full Text View

Sponsors and Collaborators:	Meiji University of Oriental Medicine Kyoto Prefectural University of Medicine
Information provided by:	Meiji University of Oriental Medicine
ClinicalTrials.gov Identifier:	NCT00718926

Purpose

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
Dry Eye Disease

MedlinePlus related topics: Eye Diseases

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control
Official Title:	The Evaluation of Thiol Redox Status in Conjunctiva of Dry Eye Patients

Further study details as provided by Meiji University of Oriental Medicine:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

After application of anethesia eyedrops, nitrocel membrane is put ocular surface. Then, removed the membrane. This method is commonly used clinically.

Estimated Enrollment:	50
Study Start Date:	August 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
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

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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
Kyoto, Japan

Sponsors and Collaborators

Meiji University of Oriental Medicine

Kyoto Prefectural University of Medicine

More Information

Responsible Party:	Meiji University of Oriental Medicine ( Jun Yamada MD. PhD. )
Study ID Numbers:	C244
Study First Received:	July 18, 2008
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00718926
Health Authority:	Japan: Institutional Review Board

Keywords provided by Meiji University of Oriental Medicine:

dry eye
Thiol redox
Oxidative stress

Study placed in the following topic categories:

Eye Diseases
Stress

ClinicalTrials.gov processed this record on January 13, 2009