The Evaluation of Thiol Redox Status in Conjunctiva of Dr... | NCT00718926

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

NCT00718926

Sponsor

Meiji University of Oriental Medicine

Status

Unknown status

Last Update Posted

Jul 21, 2008Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Dry Eye Disease

Interventions

Not provided

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Dec 2008Estimated

Completion Date

Mar 2010Estimated

First Submitted Date

Jul 18, 2008

First Submission Date that Met QC Criteria

Jul 18, 2008

First Posted Date

Jul 21, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2008

Last Update Posted Date

Jul 21, 2008Estimated

Name	Class
Kyoto Prefectural University of Medicine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

dry eye patients
control volunteers

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The dry eye patients at the clinic of Kyoto Prefectural University of Medicine hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jun Yamada, MD, PhD.	Contact	+81-75-251-5663		jyamada@koto.kpu-m.ac.jp
Norihiko Yokoi, MD, PhD.	Contact	+81-75-251-5663		nyokoi@koto.kpu-m.ac.jp

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyoto Prefectural University of Medicine hospital		Kyoto			Japan

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided