UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007235 |
|---|---|
| Receipt number | R000008528 |
| Scientific Title | bimatoprost and travoprost/timolol fixed combination in glaucoma |
| Date of disclosure of the study information | 2013/02/14 |
| Last modified on | 2021/05/23 16:24:07 |
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Basic information
Public title
bimatoprost and travoprost/timolol fixed combination in glaucoma
Acronym
bimatoprost and travoprost/timolol fixed combination in glaucoma
Scientific Title
bimatoprost and travoprost/timolol fixed combination in glaucoma
Scientific Title:Acronym
bimatoprost and travoprost/timolol fixed combination in glaucoma
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the intraocular pressure lowering effects of bimatoprost and travoprost/timolol fixed combination in eyes with open-angle glaucoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
efficacy and safety
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
bimatostost
Interventions/Control_2
travoprost/timolol fixed combination
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
primary open-angle glaucoma or normal-tension glaucoma
Key exclusion criteria
Patients with any secondary factors that might induce glaucoma such as uveitis, and lens exfoliation in even one eye were excluded. Also, patients were excluded if they had any intraocular surgery including laser therapy or had any corneal condition preventing reliable Goldmann applanation tonometry such as pterygium.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Sawada |
Organization
Gifu University Graduate School of Medicine
Division name
Ophthalmology
Zip code
501-1194
Address
1-1 Yanagido, Gifu-shi, Japan
TEL
058-230-6000
sawadaa-gif@umin.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Sawada |
Organization
Gifu University Graduate School of Medicine
Division name
Ophthalmology
Zip code
501-1194
Address
1-1 yanagido
TEL
058-230-6000
Homepage URL
sawadaa-gif@umin.ac.jp
Sponsor or person
Institute
Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Gifu University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu University Graduate School of Medicine
Address
1-1 Yanagido, Gifu-shi, Japan
Tel
058-230-6059
rinri@gifu-u.ac.jp
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
| 2013 | Year | 02 | Month | 14 | 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
| 2011 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 06 | Day |
Last modified on
| 2021 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008528
