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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001693
Receipt No. R000002038
Scientific Title the ocular hypotensive effect of tafluprost (Tapros)
Date of disclosure of the study information 2009/02/20
Last modified on 2012/04/20

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Basic information
Public title the ocular hypotensive effect of tafluprost (Tapros)
Acronym The efficacy of tafluprost
Scientific Title the ocular hypotensive effect of tafluprost (Tapros)
Scientific Title:Acronym The efficacy of tafluprost
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the ocular hypotensive effect and the safety of tafluprost.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes intraocular pressure
Key secondary outcomes adverse effect of ocular surface

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is 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 latanoprost
Interventions/Control_2 tafluprost
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 normal volunteers
Key exclusion criteria 1)abnormal finding revealed by the ophthalmological examination
2)history of ocular disease
3)previous eye surgery
4)suspected allergic reactions to the study drugs
5)inability to follow the protocol
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mochizuki, Hideki
Organization Hiroshima University
Division name Ophthalmology
Zip code
Address 1-2-3Kasumi Minamiku Hiroshima
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hiroshima University
Division name Dep. of Ophthalmology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Hiroshima University, Department of Ophthalmology
Institute
Department

Funding Source
Organization Dep. of Ophthalmology
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 02 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

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 02 Month 05 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
2009 Year 03 Month 01 Day
Date trial data considered complete
2009 Year 04 Month 01 Day
Date analysis concluded
2009 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 02 Month 06 Day
Last modified on
2012 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002038

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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