UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on objective findings and subjective symptoms in asthenopia after VDT work
Title of the study (Brief title)	A study on asthenopia after VDT work
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the relationship between subjective symptoms and objective findings of asthenopia after VDT work
Basic objectives2	Others
Basic objectives -Others	Correlation between the differences of the accommodative microfluctuation (HFC67cm) value and the VAS value in the morning and the evening
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Correlation between the differences of the accommodative microfluctuation (HFC67cm) value and the VAS value in the morning and the evening
Key secondary outcomes	1. Correlation between the differences of the value of HFC1 , HFC2 and the average of HFC value and the VAS value in the morning and the evening 2. Changes of HFC 1, HFC 67 cm, HFC 2, the average of HFC value (HFC parameters) in the morning and evening 3. Presence or absence of background factors affecting changes of HFC parameters in the morning and evening

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Measurement of accomdative microfluctuation value by ARK 560 A
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Healty adult and person who agreed to participate in this research
Key exclusion criteria	1. A person with myopia exceeding -6 D 2. A person with hyperopia 3. A person who is taking measures against presbyopia (use of reading glasses or bifocal glasses, always removing eyeglasses for VDT work, etc) 4. People who have undergone surgery of LASIK 5. Person who is aware of intense astigmatism 6. Person who is inserting multifocal intraocular lens
Target sample size	100

Research contact person
Name of lead principal investigator	Toshihide Suenobu
Organization	Senju Pharmaceutical Co., Ltd
Division name	Medical Science Department, Research & Development Division
Address	2-5-8 Hiranomachi, Chuo-ku, Osaka Japan
TEL	06-6201-2552
Email	t-suenobu@senju.co.jp

Public contact
Name of contact person	Futoshi Miyamoto
Organization	Senju Pharmaceutical Co., Ltd.
Division name	Clinical Resarch Management Group,
Address	2-5-8 Hiranomachi, Chuo-ku, Osaka Japan
TEL	06-6201-2552
Homepage URL
Email	f-miyamoto@senju.co.jp

Sponsor
Institute	Senju Pharmaceutical Co., Ltd. Clinical Resarch Management Group,
Institute
Department

Funding Source
Organization	Senju Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	千寿製薬株式会社

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 10 Day
Anticipated trial start date	2017 Year 07 Month 24 Day
Last follow-up date	2017 Year 10 Month 06 Day
Date of closure to data entry	2017 Year 10 Month 06 Day
Date trial data considered complete	2017 Year 11 Month 09 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 07 Month 10 Day
Last modified on	2018 Year 01 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032238