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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004224
Receipt No. R000005078
Scientific Title Comparison study for ocular hypotensive effect of switching from Travoprost 0.004% and Timolol maleate(Timoptol®-XE ophthalmic Solution 0.5%) ,Travoprost 0.004% and long-acting 2% Carteolol to a conbined opthalmic solution Travoprost 0.004%/Timolol 0.5%
Date of disclosure of the study information 2010/09/17
Last modified on 2011/03/10

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Basic information
Public title Comparison study for ocular hypotensive effect of switching from Travoprost 0.004% and Timolol maleate(Timoptol®-XE ophthalmic Solution 0.5%) ,Travoprost 0.004% and long-acting 2% Carteolol to a conbined opthalmic solution Travoprost 0.004%/Timolol 0.5%
Acronym Comparison study for ocular hypotensive effect of switching from Travoprost 0.004% and Timolol maleate,Travoprost 0.004% and long-acting 2% Carteolol to a conbined opthalmic solution Travoprost 0.004%/Timolol 0.5%
Scientific Title Comparison study for ocular hypotensive effect of switching from Travoprost 0.004% and Timolol maleate(Timoptol®-XE ophthalmic Solution 0.5%) ,Travoprost 0.004% and long-acting 2% Carteolol to a conbined opthalmic solution Travoprost 0.004%/Timolol 0.5%
Scientific Title:Acronym Comparison study for ocular hypotensive effect of switching from Travoprost 0.004% and Timolol maleate,Travoprost 0.004% and long-acting 2% Carteolol to a conbined opthalmic solution Travoprost 0.004%/Timolol 0.5%
Region
Japan

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

Objectives
Narrative objectives1 Comparison study for ocular hypotensive effect of switching from Travoprost 0.004% and Timolol maleate(Timoptol®-XE ophthalmic Solution 0.5%) ,Travoprost 0.004% and long-acting 2% Carteolol to a conbined opthalmic solution Travoprost 0.004%/Timolol 0.5%
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes IOP reduction
Key secondary outcomes Safety

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Investigation for efficacy,safety a conbined opthalmic solution Travoprost 0.004%/Timolol 0.5% once daily for a month into one of a subject
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 1 At Measurement for IOP base line, patient who has to fill over or equal 20 years-old 2 Out of consideration for gender, inpatient and outpatient 3.Patient, who has been managed Travoprost 0.004% and Timolol 0.5% or long-acting 2% Carteolol over a month till measurement of IOP baseline. 4.Patient, who has been accepted by Dr as candidate of switching to combination drug .
Key exclusion criteria 1Patient, who has been managed due to chronic or replace uvetis, sceritis and herpes cornea. 2.Patient, who has been managed by traumatic diseases,ocular surgery,laser operation within 3 months. 3.Patinet, who is not available to measure by Aplanation tonomater. 4.Patinet, who has irritation for PG eye solution, related PG eye solution and Benzalkonium chloride(BAC). 5.Patient, who is severe Alzheimer. 6.Patinet, who has been managed by oral CAI or steroid eye solution. 7.Patinet, who has been applied other IOP reductive drug.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiichi Nomura
Organization Yokohama City University Hospital
Division name Department of Ophthalmology
Zip code
Address 3-9 Fukuura Kanazawa-Word Yokohama city Kanagawa,Japan
TEL 045-787-2800
Email

Public contact
Name of contact person
1st name
Middle name
Last name Eiichi Nomura
Organization Yokohama City University Hospital
Division name Department of Ophthalmology
Zip code
Address 3-11 Fukuura Kanazawa-Word Yokohama city Kanagawa,Japan
TEL 045-787-2800
Homepage URL
Email

Sponsor
Institute Department of Ophthalmology Yokohama City University Hospital
Institute
Department

Funding Source
Organization Myself
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 横浜市立大学附属病院(神奈川県)/金沢病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 17 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
2010 Year 09 Month 02 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
2013 Year 09 Month 01 Day
Date of closure to data entry
2013 Year 09 Month 01 Day
Date trial data considered complete
2013 Year 12 Month 01 Day
Date analysis concluded
2013 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 09 Month 16 Day
Last modified on
2011 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005078

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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