- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00718926
The Evaluation of Thiol Redox Status in Conjunctiva of Dry Eye Patients
July 18, 2008 updated by: Meiji University of Oriental Medicine
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.
Study Overview
Status
Unknown
Conditions
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
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jun Yamada, MD, PhD.
- Phone Number: +81-75-251-5663
- Email: jyamada@koto.kpu-m.ac.jp
Study Contact Backup
- Name: Norihiko Yokoi, MD, PhD.
- Phone Number: +81-75-251-5663
- Email: nyokoi@koto.kpu-m.ac.jp
Study Locations
-
-
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Kyoto, Japan
- Kyoto Prefectural University of Medicine hospital
-
Contact:
- Shigeru Kinoshita, MD, PhD.
- Phone Number: +81-75-251-5577
- Email: shigeruk@koto.kpu-m.ac.jp
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The dry eye patients at the clinic of Kyoto Prefectural University of Medicine hospital
Description
Inclusion Criteria:
- dry eye patients
- control volunteers
Exclusion Criteria:
- Young (less than 20) patients
- The patients who rejected this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
Cohorts and Interventions
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Once a month (totally 2-4 times) at the clinic
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Anticipated)
December 1, 2008
Study Completion (Anticipated)
March 1, 2010
Study Registration Dates
First Submitted
July 18, 2008
First Submitted That Met QC Criteria
July 18, 2008
First Posted (Estimate)
July 21, 2008
Study Record Updates
Last Update Posted (Estimate)
July 21, 2008
Last Update Submitted That Met QC Criteria
July 18, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C244
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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