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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005062
Receipt No. R000006022
Scientific Title Switching test from latanoprost to travoprost/timolol ophthalmic solution
Date of disclosure of the study information 2011/02/13
Last modified on 2011/12/28

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Basic information
Public title Switching test from latanoprost to travoprost/timolol ophthalmic solution
Acronym Switching test to travoprost/timolol ophthalmic solution
Scientific Title Switching test from latanoprost to travoprost/timolol ophthalmic solution
Scientific Title:Acronym Switching test to travoprost/timolol ophthalmic solution
Region
Japan

Condition
Condition Primary open angle glaucoma and ocular hypertension
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparing efficacy and safety of travoprost/timolol ophthalmic solution with latanoprost ophthalmic solution
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes intra ocular pressure, blood pressure, pulse rate, corneal erosion, hyperemia
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Swtiching from latanoprost ophthalmic solution to travoprost/timolol ophthalmic solution
Interventions/Control_2
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 Need anti-glaucoma therapy
Key exclusion criteria active ocular diseases, severe heart and pulmonary diseases, history of allergy against employed ophthalmic solutions, less than six months after any incisional ocular surgery and ocluar trauma, and any other conditions that doctor recognizes inadequate for enrollment
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Iijima
Organization University of Yamanashi
Division name Ophthalmology
Zip code
Address 1110 Shimokato Chuo Yamanashi
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazumi Okudaira
Organization University of Yamanashi
Division name Community and Family Medicine
Zip code
Address 1110 Shimokato Chuo Yamanashi
TEL
Homepage URL
Email

Sponsor
Institute Association for Research in Supporting System of Chronic Diseases
Institute
Department

Funding Source
Organization Self funding
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
2011 Year 02 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
2010 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 02 Month 10 Day
Last modified on
2011 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006022

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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