UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The change of cytokines in tear fluid with dry eye patients after rebamipide instillation
Title of the study (Brief title)	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	Noda Kousuke
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Ophthalmology
Address	Kita 15 Nishi 7, kita-ku, Sapporo
TEL	011-706-5944
Email	nodako@med.hokudai.ac.jp

Public contact
Name of contact person	Noda Kousuke
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Ophthalmology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000023871