UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014938 |
|---|---|
| Receipt number | R000017380 |
| Scientific Title | Evaluation of blink on Blepharospasm and the change by botox treatment |
| Date of disclosure of the study information | 2014/08/24 |
| Last modified on | 2016/04/09 16:44:03 |
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Basic information
Public title
Evaluation of blink on Blepharospasm and the change by botox treatment
Acronym
Evaluation of blink on Blepharospasm
Scientific Title
Evaluation of blink on Blepharospasm and the change by botox treatment
Scientific Title:Acronym
Evaluation of blink on Blepharospasm
Region
| Japan |
Condition
Condition
healthy volunteer,dry eye, blepharospasm
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the difference of blink among blepharospasm, dry eye and healthy volunteers. To investigate blink change by botox treatment on blepharospasm patients.
Basic objectives2
Others
Basic objectives -Others
exploratory trial
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blink parameters
Key secondary outcomes
Base
Study type
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
Botox Treatment for blepharospasm
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
Dry eye patients
Blepharospasm patients
healthy volunteers as control
Key exclusion criteria
people who had ophthalmic surgery within 6 months
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoko Kawashima |
Organization
Haneginomori eye clinic
Division name
Department of Ophthalmology
Zip code
Address
4-26-4, Daita, Setagayaku, Tokyo 155-0033 Japan
TEL
03-6265-8777
motoko326@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoko Kawashima |
Organization
Haneginomori eye clinic
Division name
Ophthalmology
Zip code
Address
4-26-4, Daita, Setagayaku, Tokyo 155-0033 Japan
TEL
03-6265-8777
Homepage URL
motoko326@gmail.com
Sponsor or person
Institute
Haneginomori eye clinic
Institute
Department
Personal name
Funding Source
Organization
JIN CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Minamiaoyama eye clinic, Kiyosawa Eye clinic
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
羽根木の森アイクリニック、南青山アイクリニック、清澤眼科医院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | 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
| 2014 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 24 | Day |
Last modified on
| 2016 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017380
