UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005974 |
|---|---|
| Receipt number | R000007039 |
| Scientific Title | Comparison of travoprost and latanoprost plus timolol fixed combinations in open-angle glaucoma and ocular hypertension patients previously treated with dorzolamide plus timolol fixed combination. |
| Date of disclosure of the study information | 2011/07/15 |
| Last modified on | 2012/10/01 07:05:35 |
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Basic information
Public title
Comparison of travoprost and latanoprost plus timolol fixed combinations in open-angle glaucoma and ocular hypertension patients previously treated with dorzolamide plus timolol fixed combination.
Acronym
Comparison of travoprost and latanoprost plus timolol fixed combinations in patients previously treated with dorzolamide plus timolol fixed combination.
Scientific Title
Comparison of travoprost and latanoprost plus timolol fixed combinations in open-angle glaucoma and ocular hypertension patients previously treated with dorzolamide plus timolol fixed combination.
Scientific Title:Acronym
Comparison of travoprost and latanoprost plus timolol fixed combinations in patients previously treated with dorzolamide plus timolol fixed combination.
Region
| Japan |
Condition
Condition
primary open angle glaucoma, normal tension glaucoma and ocular hypertension patients
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the ocular hypotensive effect
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraocular pressure
Key secondary outcomes
The incidence rate of side effect
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
drug intervention
Interventions/Control_2
drug intervention
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
primary open angle glaucoma, normal tension glaucoma and ocular hypertension patients
Key exclusion criteria
neuro-ophthalmic disease and chorioretinopathy patients
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Kanda |
Organization
National Defense Medical College
Division name
Department of Ophthalmology
Zip code
Address
3-2, Namiki, Tokorozawa, Saitama
TEL
04-2995-1683
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuhei Shoji |
Organization
National Defense Medical College
Division name
Department of Ophthalmology
Zip code
Address
TEL
Homepage URL
shoojii-oph@umin.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
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
| 2011 | Year | 07 | Month | 15 | 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
| 2010 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 14 | Day |
Last modified on
| 2012 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007039
