UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015823 |
|---|---|
| Receipt number | R000018087 |
| Scientific Title | Switching from latanoprost or travoprost ophthalmolic solution to tafruprost and timolol fixed ophthalmic solution |
| Date of disclosure of the study information | 2014/12/05 |
| Last modified on | 2016/06/02 09:10:57 |
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Basic information
Public title
Switching from latanoprost or travoprost ophthalmolic solution to tafruprost and timolol fixed ophthalmic solution
Acronym
Switching from latanoprost or travoprost to tafruprost and timolol fixed ophthalmic solution
Scientific Title
Switching from latanoprost or travoprost ophthalmolic solution to tafruprost and timolol fixed ophthalmic solution
Scientific Title:Acronym
Switching from latanoprost or travoprost to tafruprost and timolol fixed ophthalmic solution
Region
| Japan |
Condition
Condition
Primary open angle glaucoma and ocular hypertension
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of tafloprost and timolol fixed combination by switching latanoprost or travoprost monotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reduction of intraocular pressure
Topical and systemic adverse effects
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
Switching from latanoprost or travoprost monotherapy to tafluprost/timolol fixed combination
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
Primary open angle glaucoma
Ocular hypertension
Key exclusion criteria
Severe respiratory diseases
Severe systemic diseases
Allegic reaction against contents of the experimental compounds
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
Ophthalmology
Zip code
Address
1110 Shimokato Chuo Yamanashi
TEL
055-273-1111
kenjik@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Kashiwagi |
Organization
University of Yamanashi
Division name
Ophthalmology
Zip code
Address
1110 Shimokato Chuo Yamanashi
TEL
055-273-1111
Homepage URL
kenjik@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmaceitical Co. Ltd
Organization
Division
Category of Funding Organization
Profit 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
| 2014 | Year | 12 | Month | 05 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 02 | Day |
Last modified on
| 2016 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018087
