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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001874
Receipt No. R000002245
Scientific Title Comparative study of efficacy and safty of Travatanz and Xalatan
Date of disclosure of the study information 2009/04/11
Last modified on 2012/10/30

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Basic information
Public title Comparative study of efficacy and safty of Travatanz and Xalatan
Acronym Comparative study of efficacy and safty of Travatanz and Xalatan
Scientific Title Comparative study of efficacy and safty of Travatanz and Xalatan
Scientific Title:Acronym Comparative study of efficacy and safty of Travatanz and Xalatan
Region
Japan

Condition
Condition glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare efficacy and safty of Travatanz and Xalatan
Basic objectives2 Others
Basic objectives -Others change of tear
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intraocular pressure, hyperemia
Key secondary outcomes tear

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 xalatan to one eye
Interventions/Control_2 travatanz to fellow eye
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Primary open angle glaucma
Key exclusion criteria history of intraocular surgery
advanced glaucoma patient
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name daisuke shiba
Organization Keio University
Division name dept. ophthalmology
Zip code
Address 35 shinanomachi, shinjuku-ku, tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Keio University
Division name dept. ophthalmology
Zip code
Address
TEL 03-3353-1211
Homepage URL
Email

Sponsor
Institute keio university
school of medicine
department of ophthalmology
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
2009 Year 04 Month 11 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
2009 Year 04 Month 08 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2012 Year 06 Month 14 Day
Date trial data considered complete
2012 Year 06 Month 14 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 04 Month 11 Day
Last modified on
2012 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002245

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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