UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective Observational Study Using the QOL Scale for Rebamipde Ophthalmic Suspension Treatment in the Dry Eye Syndrome Patient
Title of the study (Brief title)	Retrospective Observational Study Using the QOL Scale for Rebamipde Ophthalmic Suspension Treatment in the Dry Eye Syndrome Patient
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of continuous change of the DEQS(Dry Eye related Quality of life Score) for rebamipde ophthalmic suspension treatment in the Dry Eye syndrome patient and examine correlation between DEQS and dry eye views
Basic objectives2	Others
Basic objectives -Others	Continual change of DEQS
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Continual change of DEQS
Key secondary outcomes	Correlation of DEQS and Patient Characteristics Correlation of DEQS and Schirmer test or BUT Correlation of DEQS and TSAS-RBUT Correlation of DEQS and keratoconjunctivitis Incidence of side effect

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	1.Outpatients who be diagnosis of Dry Eye and treat with Rebamipide in Ehime University Hospital from Apr 2013 to Mar 31 2016 2.Patients of 20 years or older at the time of the DEQS interview before the start of therapy
Key exclusion criteria	1.Patients who receive surgical treatment having an influence on cornea and the tear during a investigation period 2.Patients judged by the principal investigator/sub-investigator to be unable to be included in the study
Target sample size	70

Research contact person
Name of lead principal investigator	Yuri Sakane
Organization	Ehime University School of Medicine
Division name	Ophthalmology
Address	Shizukawa, Tohon-city, Ehime, Japan
TEL	089-960-5361
Email	y-sakane@m.ehime-u.ac.jp

Public contact
Name of contact person	Yuri Sakane
Organization	Ehime University School of Medicine
Division name	Ophthalmology
Address	Shizukawa, Tohon-city, Ehime, Japan
TEL	089-960-5361
Homepage URL
Email	y-sakane@m.ehime-u.ac.jp

Sponsor
Institute	Ophthalmology, Ehime University school of Medicine
Institute
Department

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

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	愛媛大学医学部附属病院（愛媛県）

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 01 Day
Anticipated trial start date	2016 Year 10 Month 18 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	none

Management information
Registered date	2016 Year 10 Month 14 Day
Last modified on	2018 Year 10 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027911