UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Biochemical analysis of tear composition in dry eye patients
Title of the study (Brief title)	Biochemical analysis of tear composition
Region	Japan

Condition
Condition	Dry eye
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To analyze the tear compostion, including tear proteins and lipids, in patients with dry eye
Basic objectives2	Others
Basic objectives -Others	To investigate the composition which plays a role in pathophysiology of dry eye, which may lead to future treatment.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Tears are colloected by Schirmer test strips from the dry eye patints, which are clinically performed. After the elution of tear protein and lipid, total protein and lactoferrinm lipocalin, lysozyme and secretory IgA are measured. And cytokines, phospholipase A2, lipids are fractioned and quantified.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Dry eye patients (defined by the diagnostic criteria of Japan dry eye society 2006)
Key exclusion criteria	1) Complication of anterior disease(blepharitis, lagophthalmos, blepharospasm and iritis) other than dry eye ( patients with past history of the above disease are included). 2) Patients who were assessed as inadequate.
Target sample size	100

Research contact person
Name of lead principal investigator	Masakazu Yamada
Organization	National Hospital Organization Tokyo Medical Center
Division name	Division for Vision Research, National Institute of Sensory Organs
Address	2-5-1 Higashigaoka, Meguro-ku, Tokyo 152-8982 Japan
TEL	03-3411-0379
Email	yamada@eye-center.org

Public contact
Name of contact person	Chika Shigeyasu
Organization	National Hospital Organization Tokyo Medical Center
Division name	Division for Vision Research, National Institute of Sensory Organs
Address	2-5-1 Higashigaoka, Meguro-ku, Tokyo 152-8982 Japan
TEL	03-3411-0379
Homepage URL
Email	shigeyasu@kankakuki.go.jp

Sponsor
Institute	Department of Ophthalmology, National Hospital Organization Tokyo Medical Center
Institute
Department

Funding Source
Organization	Department of Ophthalmology, National Institute of Sensory Organs, National Hospital Organization Tokyo Medical Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 20 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2010 Year 07 Month 07 Day
Anticipated trial start date	2010 Year 07 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	It is a study using Schirmer test, which is normally performed in dry eye patients.

Management information
Registered date	2017 Year 01 Month 19 Day
Last modified on	2017 Year 01 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029625