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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024405
Receipt No. R000027911
Scientific Title Retrospective Observational Study Using the QOL Scale for Rebamipde Ophthalmic Suspension Treatment in the Dry Eye Syndrome Patient
Date of disclosure of the study information 2016/10/18
Last modified on 2018/10/23

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Basic information
Public title Retrospective Observational Study Using the QOL Scale for Rebamipde Ophthalmic Suspension Treatment in the Dry Eye Syndrome Patient
Acronym Retrospective Observational Study Using the QOL Scale for Rebamipde Ophthalmic Suspension Treatment in the Dry Eye Syndrome Patient
Scientific Title Retrospective Observational Study Using the QOL Scale for Rebamipde Ophthalmic Suspension Treatment in the Dry Eye Syndrome Patient
Scientific Title:Acronym 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
1st name
Middle name
Last name Yuri Sakane
Organization Ehime University School of Medicine
Division name Ophthalmology
Zip code
Address Shizukawa, Tohon-city, Ehime, Japan
TEL 089-960-5361
Email y-sakane@m.ehime-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuri Sakane
Organization Ehime University School of Medicine
Division name Ophthalmology
Zip code
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)

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 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

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
2016 Year 10 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000027911

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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