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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024370
Receipt No. R000028031
Scientific Title Biochemical analysis of tear composition in dry eye patients
Date of disclosure of the study information 2016/10/17
Last modified on 2019/04/15

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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 No longer recruiting
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
2018 Year 03 Month 31 Day
Date of closure to data entry
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
2019 Year 04 Month 15 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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