UMIN-CTR Clinical Trial

Basic information
Public title	Biochemical analysis of tear composition in dry eye patients
Acronym	Biochemical analysis of tear composition
Scientific Title	Biochemical analysis of tear composition in dry eye patients
Scientific Title:Acronym	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	1st name Masakazu Middle name Last name Yamada
Organization	Kyorin University School of Medicine
Division name	Department of Ophthalmology
Zip code	1818611
Address	Shinkawa,
TEL	0422475511
Email	yamada@eye-center.org

Public contact
Name of contact person	1st name Chika Middle name Last name Shigeyasu
Organization	Kyorin University School of Medicine
Division name	Department of Ophthalmology
Zip code	1818611
Address	6-20-2 Shinkawa, Mitaka, Tokyo
TEL	0422-47-5511
Homepage URL
Email	shigeyasu@eye-center.org

Sponsor
Institute	Department of Ophthalmology, Kyorin University School of Medicine
Institute
Department

Funding Source
Organization	Department of Ophthalmology, Kyorin University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kyorin University School of Medicine
Address	6-20-2 Shinkawa, Mitaka, Tokyo
Tel	0422-47-5511
Email	irb@ks.kyorin-u.ac.jp

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	2016 Year 10 Month 17 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Suspended
Date of protocol fixation	2015 Year 08 Month 31 Day
Date of IRB	2015 Year 09 Month 24 Day
Anticipated trial start date	2015 Year 09 Month 24 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry	2024 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	Since it is a study using the normally performed Schirmer test, there have been no trouble carrying out the study. However, the patient registration are needed to be increased.

Management information
Registered date	2016 Year 10 Month 12 Day
Last modified on	2021 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028031