UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024405 |
|---|---|
| Receipt number | 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 12:43:29 |
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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
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
y-sakane@m.ehime-u.ac.jp
Sponsor or person
Institute
Ophthalmology, Ehime University school of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027911
