UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017687 |
|---|---|
| Receipt number | R000020200 |
| Scientific Title | Efficacy and safety of a switch to latanoprost 0.005% + timolol maleate 0.5% fixed combination eyedrops from tafluprost 0.0015% monotherapy. |
| Date of disclosure of the study information | 2015/05/26 |
| Last modified on | 2016/03/08 18:30:30 |
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Basic information
Public title
Efficacy and safety of a switch to latanoprost 0.005% + timolol maleate 0.5% fixed combination eyedrops from tafluprost 0.0015% monotherapy.
Acronym
Efficacy and safety of a switch to latanoprost 0.005% + timolol maleate 0.5% fixed combination eyedrops from tafluprost 0.0015% monotherapy.
Scientific Title
Efficacy and safety of a switch to latanoprost 0.005% + timolol maleate 0.5% fixed combination eyedrops from tafluprost 0.0015% monotherapy.
Scientific Title:Acronym
Efficacy and safety of a switch to latanoprost 0.005% + timolol maleate 0.5% fixed combination eyedrops from tafluprost 0.0015% monotherapy.
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safty of a switch to latanoprost/timolol fixed combination from tafluprost monotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intraocuar pressure
Key secondary outcomes
complications
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switch to latanoprost/timolol fixed combination from tafluprost monotherapy
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
# Inadequate intraocular pressure reduction in tafulprost monotherapy
# Primary open angle glaucoma
Key exclusion criteria
# Angle closure
# History of glaucoma surgery
# Bronchial asthma
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Shiba |
Organization
Keio University School of medicine
Division name
Department of ophthalmolgoy
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
shiba@personal.email.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Shiba |
Organization
Keio university school of medicine
Division name
Department of ophthalmology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
shiba@personal.email.ne.jp
Sponsor or person
Institute
Department of Ophthalmology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funiding
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
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
日本医科大学附属病院（東京都）、東京女子医科大学附属病院（東京都）、東京慈恵会医科大学病院（東京都）、済安堂 井上眼科病院（東京都）、慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 26 | 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
| 2013 | Year | 05 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 13 | 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
| 2015 | Year | 05 | Month | 26 | Day |
Last modified on
| 2016 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020200
