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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002757
Receipt No. R000003351
Scientific Title Clinical effects of once daily-type beta-blockers in glaucoma patients
Date of disclosure of the study information 2009/11/13
Last modified on 2014/05/12

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Basic information
Public title Clinical effects of once daily-type beta-blockers in glaucoma patients
Acronym Clinical effects of once daily-type beta-blockers in glaucoma patients
Scientific Title Clinical effects of once daily-type beta-blockers in glaucoma patients
Scientific Title:Acronym Clinical effects of once daily-type beta-blockers in glaucoma patients
Region
Japan

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

Objectives
Narrative objectives1 To compare the IOP reducing effect and prevalence of side effects between topical treatments with Rysmon TG and Mikelan LA.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes visual acuity, intraocular pressure, frequency of side effects
Key secondary outcomes

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 Rysmon TG-Mikelan LA
Interventions/Control_2 Mikelan LA-Rysmon TG
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria glaucoma
Key exclusion criteria None
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Tanito
Organization Shimane University Faculty of Medicine
Division name Ophthalmology
Zip code
Address Enya 89-1, Izumo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Shimane University Faculty of Medicine
Division name Department of Ophthalmology
Zip code
Address
TEL
Homepage URL
Email tanito-oph@umin.ac.jp

Sponsor
Institute Departmet of Ophthalmology, Shimane University Faculty 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
2009 Year 11 Month 13 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 11 Month 12 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2014 Year 04 Month 30 Day
Date of closure to data entry
2014 Year 04 Month 30 Day
Date trial data considered complete
2014 Year 04 Month 30 Day
Date analysis concluded
2014 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2009 Year 11 Month 12 Day
Last modified on
2014 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003351

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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