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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006763
Receipt No. R000007442
Scientific Title Topical and oral tranilast for treatment of dry eye associated with chronic graft-versus-host disease
Date of disclosure of the study information 2011/12/01
Last modified on 2016/02/10

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Basic information
Public title Topical and oral tranilast for treatment of dry eye associated with chronic graft-versus-host disease
Acronym Effect of tranilast for treatment of dry eye
Scientific Title Topical and oral tranilast for treatment of dry eye associated with chronic graft-versus-host disease
Scientific Title:Acronym Effect of tranilast for treatment of dry eye
Region
Japan

Condition
Condition Dry eye related to cGVHD
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigated the efficacy and safety of topical or oral tranilast for dry eye associated with cGVHD
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes visual analog scale
ocular surface vital staining
tear break up time
value of schirmer test
value of nasal stimulation test
Key secondary outcomes visual acuity
functional visual acuity
tear stability analysis system
tear lipid interferometory

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Topical tranilast
Interventions/Control_2 Oral tranilast
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Diagnostic criteria
Tear Dynamics
Schirmer test &#8804; 5 mm
Tear break up time &#8804; 5 sec
Ocular surface condition
Rose Bengal staining &#8805; 3 points
Fluorescein staining &#8805; 3 points



Newly onset of dry eye patients after hematopoietic stem cell transplantation
Key exclusion criteria Contact lens wearer
Infectious disease
Other ocular disease
Target sample size 44

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoko Ogawa
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 35 Shinanomachi Shinjuku-ku, Tokyo, 160-8582, Japan
TEL 03-3353-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoko Ogawa
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 35 Shinanomachi Shinjuku-ku, Tokyo, 160-8582, Japan
TEL 03-5363-3972
Homepage URL
Email

Sponsor
Institute Department of Ophthalmology, Keio University SchooL of medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2011 Year 12 Month 01 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
2011 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 11 Month 24 Day
Last modified on
2016 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007442

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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