UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of blink on Blepharospasm and the change by botox treatment
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Motoko Kawashima
Organization	Haneginomori eye clinic
Division name	Department of Ophthalmology
Address	4-26-4, Daita, Setagayaku, Tokyo 155-0033 Japan
TEL	03-6265-8777
Email	motoko326@gmail.com

Public contact
Name of contact person	Motoko Kawashima
Organization	Haneginomori eye clinic
Division name	Ophthalmology
Address	4-26-4, Daita, Setagayaku, Tokyo 155-0033 Japan
TEL	03-6265-8777
Homepage URL
Email	motoko326@gmail.com

Sponsor
Institute	Haneginomori eye clinic
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000017380