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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005974
Receipt No. R000007039
Scientific Title Comparison of travoprost and latanoprost plus timolol fixed combinations in open-angle glaucoma and ocular hypertension patients previously treated with dorzolamide plus timolol fixed combination.
Date of disclosure of the study information 2011/07/15
Last modified on 2012/10/01

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Basic information
Public title Comparison of travoprost and latanoprost plus timolol fixed combinations in open-angle glaucoma and ocular hypertension patients previously treated with dorzolamide plus timolol fixed combination.
Acronym Comparison of travoprost and latanoprost plus timolol fixed combinations in patients previously treated with dorzolamide plus timolol fixed combination.
Scientific Title Comparison of travoprost and latanoprost plus timolol fixed combinations in open-angle glaucoma and ocular hypertension patients previously treated with dorzolamide plus timolol fixed combination.
Scientific Title:Acronym Comparison of travoprost and latanoprost plus timolol fixed combinations in patients previously treated with dorzolamide plus timolol fixed combination.
Region
Japan

Condition
Condition primary open angle glaucoma, normal tension glaucoma and ocular hypertension patients
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 the ocular hypotensive effect
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intraocular pressure
Key secondary outcomes The incidence rate of side effect

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Uncontrolled
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 drug intervention
Interventions/Control_2 drug intervention
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
80 years-old >
Gender Male and Female
Key inclusion criteria primary open angle glaucoma, normal tension glaucoma and ocular hypertension patients
Key exclusion criteria neuro-ophthalmic disease and chorioretinopathy patients
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayuki Kanda
Organization National Defense Medical College
Division name Department of Ophthalmology
Zip code
Address 3-2, Namiki, Tokorozawa, Saitama
TEL 04-2995-1683
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takuhei Shoji
Organization National Defense Medical College
Division name Department of Ophthalmology
Zip code
Address
TEL
Homepage URL
Email shoojii-oph@umin.ac.jp

Sponsor
Institute Department of Ophthalmology, National Defense Medical College
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization
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 07 Month 15 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
2010 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2012 Year 04 Month 01 Day
Date of closure to data entry
2012 Year 07 Month 01 Day
Date trial data considered complete
2012 Year 10 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 07 Month 14 Day
Last modified on
2012 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007039

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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