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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007235
Receipt No. R000008528
Scientific Title bimatoprost and travoprost/timolol fixed combination in glaucoma
Date of disclosure of the study information 2013/02/14
Last modified on 2016/09/30

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Basic information
Public title bimatoprost and travoprost/timolol fixed combination in glaucoma
Acronym bimatoprost and travoprost/timolol fixed combination in glaucoma
Scientific Title bimatoprost and travoprost/timolol fixed combination in glaucoma
Scientific Title:Acronym bimatoprost and travoprost/timolol fixed combination in glaucoma
Region
Japan

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

Objectives
Narrative objectives1 To compare the intraocular pressure lowering effects of bimatoprost and travoprost/timolol fixed combination in eyes with open-angle glaucoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes efficacy and safety
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
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 bimatostost
Interventions/Control_2 travoprost/timolol fixed combination
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 primary open-angle glaucoma or normal-tension glaucoma
Key exclusion criteria Patients with any secondary factors that might induce glaucoma such as uveitis, and lens exfoliation in even one eye were excluded. Also, patients were excluded if they had any intraocular surgery including laser therapy or had any corneal condition preventing reliable Goldmann applanation tonometry such as pterygium.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Sawada
Organization Gifu University Graduate School of Medicine
Division name Ophthalmology
Zip code
Address 1-1 Yanagido, Gifu-shi, Japan
TEL 058-230-6000
Email sawadaa-gif@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Sawada
Organization Gifu University Graduate School of Medicine
Division name Ophthalmology
Zip code
Address 1-1 yanagido
TEL 058-230-6000
Homepage URL
Email sawadaa-gif@umin.ac.jp

Sponsor
Institute Gifu University Graduate School of Medicine
Institute
Department

Funding Source
Organization Gifu University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
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
2013 Year 02 Month 14 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 Enrolling by invitation
Date of protocol fixation
2011 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
2013 Year 04 Month 01 Day
Date of closure to data entry
2013 Year 04 Month 01 Day
Date trial data considered complete
2013 Year 04 Month 01 Day
Date analysis concluded
2013 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 02 Month 06 Day
Last modified on
2016 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008528

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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