NCT00718926

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2008

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

July 21, 2008

Status Verified

May 1, 2008

Enrollment Period

4 months

First QC Date

July 18, 2008

Last Update Submit

July 18, 2008

Conditions

Dry Eye Disease

Keywords

dry eyeThiol redoxOxidative stress

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

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

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • dry eye patients
  • control volunteers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyoto Prefectural University of Medicine hospital

Kyoto, Japan

Location

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.

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Central Study Contacts

Jun Yamada, MD, PhD.

CONTACT

+81-75-251-5663jyamada@koto.kpu-m.ac.jp

Norihiko Yokoi, MD, PhD.

CONTACT

+81-75-251-5663nyokoi@koto.kpu-m.ac.jp

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2008

First Posted

July 21, 2008

Study Start

August 1, 2008

Primary Completion

December 1, 2008

Study Completion

March 1, 2010

Last Updated

July 21, 2008

Record last verified: 2008-05

Locations

JP(1)