UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010081 |
|---|---|
| Receipt number | R000011808 |
| Scientific Title | Efficacy and safety of switching to bimatoprost or dorzoramide/timolol fixed-combination therapy from latanoprost monotherapy |
| Date of disclosure of the study information | 2013/02/20 |
| Last modified on | 2013/06/28 10:17:55 |
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Basic information
Public title
Efficacy and safety of switching to bimatoprost or dorzoramide/timolol fixed-combination therapy from latanoprost monotherapy
Acronym
Change to bimatoprost or dorzoramide/timolol from latanoprost
Scientific Title
Efficacy and safety of switching to bimatoprost or dorzoramide/timolol fixed-combination therapy from latanoprost monotherapy
Scientific Title:Acronym
Change to bimatoprost or dorzoramide/timolol from latanoprost
Region
| Japan |
Condition
Condition
Primary open angle glaucoma or ocular hypertension
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of switching to dorzoramide/timolol fixed-combination therapy or bimatoprost from latanoprost monotherapy should be investigated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Intra-ocular pressure
Key secondary outcomes
Ocular adverse effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
One eye randomly changed to bimatoprost ophthalmic sollutions from latanoprost ophthalmic solution.
Latanoprost ophthalmic solution was resumed 12 weeks later.
Interventions/Control_2
The other eye changed to dorzoramide/timolol ophthalmic sollutions from latanoprost ophthalmic solution.
Latanoprost ophthalmic solution was resumed 12 weeks later.
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
Patients with primary open angle glaucoma or ocular hypertension
Key exclusion criteria
Other severe ocular diseases
Contra-indication for experiment ophthalmic solutions
Problems for intra-ocular pressure measurement
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Kashiwagi |
Organization
University of Yamanashi
Division name
Department of Ophthalmology
Zip code
Address
1110 Shimokato Chuo Yamanashi
TEL
055-273-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Kashiwagi |
Organization
University of Yamanashi
Division name
Department of Ophthalmology
Zip code
Address
1110 Shimokato Chuo Yamanashi
TEL
055-273-1111
Homepage URL
Sponsor or person
Institute
Association for research and science supporting for chronic diseases
Institute
Department
Personal name
Funding Source
Organization
Self funding
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 | 02 | Month | 20 | 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
Bimatoprost monotherapy and concomittant usage of brinzolamide to latanoprost monotherapy significantly reduce intraocular pressure compared with latanoprost monotherapy at the same level.
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 | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 26 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 26 | Day |
Date trial data considered complete
| 2013 | Year | 06 | Month | 26 | Day |
Date analysis concluded
| 2013 | Year | 07 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 20 | Day |
Last modified on
| 2013 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011808
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| Registered date | File name |
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| Registered date | File name |
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