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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020691
Receipt No. R000023871
Scientific Title The change of cytokines in tear fluid with dry eye patients after rebamipide instillation
Date of disclosure of the study information 2016/01/22
Last modified on 2017/07/25

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Basic information
Public title The change of cytokines in tear fluid with dry eye patients after rebamipide instillation
Acronym Rebamipide cytokines
Scientific Title The change of cytokines in tear fluid with dry eye patients after rebamipide instillation
Scientific Title:Acronym Rebamipide cytokines
Region
Japan

Condition
Condition dry eye disease
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the change of cytokines, proteins and neuropeptide in tear fluid before and after rebamipide treatment
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of cytokines in tear fluid
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
90 years-old >=
Gender Male and Female
Key inclusion criteria The dry eye patients who understood enough and agreed with this study
Key exclusion criteria Inappropriate patients
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noda Kousuke
Organization Hokkaido University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address Kita 15 Nishi 7, kita-ku, Sapporo
TEL 011-706-5944
Email nodako@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noda Kousuke
Organization Hokkaido University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address Kita 15 Nishi 7, kita-ku, Sapporo
TEL 011-706-5944
Homepage URL
Email nodako@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 01 Month 22 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 Completed
Date of protocol fixation
2014 Year 11 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Under review

Management information
Registered date
2016 Year 01 Month 21 Day
Last modified on
2017 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023871

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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