UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004224 |
|---|---|
| Receipt number | 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 21:09:41 |
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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
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
Sponsor or person
Institute
Department of Ophthalmology Yokohama City University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005078
