UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010978 |
|---|---|
| Receipt number | R000012790 |
| Scientific Title | Efficacy of switching to 0.1% Brimonidine Tartrate in glaucoma patients under combined theraphy. |
| Date of disclosure of the study information | 2013/06/24 |
| Last modified on | 2013/06/17 13:28:17 |
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Basic information
Public title
Efficacy of switching to 0.1% Brimonidine Tartrate in glaucoma patients under combined theraphy.
Acronym
Efficacy of switching to 0.1% Brimonidine Tartrate.
Scientific Title
Efficacy of switching to 0.1% Brimonidine Tartrate in glaucoma patients under combined theraphy.
Scientific Title:Acronym
Efficacy of switching to 0.1% Brimonidine Tartrate.
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For glaucoma patients in treatment of multi-drug combination, were studied retrospectively effect lowering eye pressure when you switch to 0.1% brimonidine tartrate ophthalmic solution 1 agents already in use.
In addition, we are considering a similar study for eye drops other future.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Target 32 eye 19 cases glaucome patients during the period April 2013 from June 2012, to perform the treatment combination multidrug in Yamagata University Medical Hospital ophthalmology hospital was also determined effect is insufficient clinically. Were compared before and after the switch to 0.1% brimonidine tartrate ophthalmic solution 1 agents already in use without providing the washout period, the switching effect lowering IOP.
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
Period, between April 2013 from June 2012. Target, 32 eye 19 cases of glaucoma patients Yamagata University Medical Hospital ophthalmology hospital.
The method, and tha results were compared before and after the switch to 0.1% brimonidine tartrate ophthalmic solution 1 agents already in use without providing the washout period, the switching effect lowering IOP.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Glaucoma patient to be treated multidrug combination was also determined effect is insufficient clinically.
Key exclusion criteria
Glaucoma patient that it is determined effect is sufficient clinically in the treatment of current.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michi Nagasawa |
Organization
Yamagata University Medical Hospital
Division name
Ophthalmology
Zip code
Address
2-2-2 Iidanishi Yamagata
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yamagata University Medical Hospital
Division name
Ophthalmology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Ophthalmology, Yamagata University Medical Hospital.
Institute
Department
Personal name
Funding Source
Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 24 | 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
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 17 | Day |
Last modified on
| 2013 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012790
