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

Dry Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00718926
• Other study ID #: C244
• Status: Not yet recruiting
• Phase: N/A
• First received: July 18, 2008
• Last updated: July 18, 2008
• Start date: August 2008
• Est. completion date: March 2010

Study information

• Verified date: May 2008
• Source: Meiji University of Oriental Medicine
• Contact: Jun Yamada, MD, PhD.
• Phone: +81-75-251-5663
• Email: jyamada[@]koto.kpu-m.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• dry eye patients

• control volunteers

Exclusion Criteria:

• Young (less than 20) patients

• The patients who rejected this study

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Locations

Country	Name	City	State
Japan	Kyoto Prefectural University of Medicine hospital	Kyoto

Sponsors (2)

Lead Sponsor	Collaborator
Meiji University of Oriental Medicine	Kyoto Prefectural University of Medicine

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear amount, tear break up time, and so on are measured clinically. The thiol redox status is measured by staining the membrane.		Once a month (totally 2-4 times) at the clinic	Yes