UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004818 |
|---|---|
| Receipt number | R000005681 |
| Scientific Title | Quantitative analysis of effect of topical tafluprost on ocular blood flow in normal subjects |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2013/02/05 08:26:15 |
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Basic information
Public title
Quantitative analysis of effect of topical tafluprost on ocular blood flow in normal subjects
Acronym
Tafluprost and ocular blood flow
Scientific Title
Quantitative analysis of effect of topical tafluprost on ocular blood flow in normal subjects
Scientific Title:Acronym
Tafluprost and ocular blood flow
Region
| Japan |
Condition
Condition
normal subjects
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effect of topical tafluprost on ocular blood flow in normal subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantitative index of blood velocity in ocular tissues obtained with laser speckle method
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Unilateral eyes with topical tafluprost instillation (unilateral)
Interventions/Control_2
Contralateral eyes without drug instillation
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Normal subjects not falling under the exclusion criteria
Key exclusion criteria
History or presence of systemic diseases that could affect general circulation including hyper tension, cardiac diseases, diabetes mellitus, or arterial sclerosis.
History or presence of ocular diseases that could affect measurement of ocular blood flow including cataract, diabetic retinopathy/maculopathy, age-related macular degeneration, glaucoma and optic nerve or retinal abnormality.
History of intraocular or refractive surgery.
Habitual smoking, pregnancy, or lactation.
Those judged to be inappropriate for the participation by the responsible researchers.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chiro Mayama |
Organization
University of Tokyo Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
7-3-1, hongo, bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of Tokyo Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
7-3-1, hongo, bunkyo-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Department of Ophthalmology,University of Tokyo Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2012 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2011 | Year | 01 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2012 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 04 | Day |
Last modified on
| 2013 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005681
