UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research on the efficacy and safety of physical therapy in visual display terminals (VDTs) users : Kao-001
Title of the study (Brief title)	Efficacy evaluation test of physical therapy in VDT users
Region	Asia(except Japan)

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the efficacy and safety of physical therapy in VDT users with eye discomfort
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Subject-administrated questionnaires on eye discomfort and vision-related quality of life in single / 2-week repeated treatment with physical therapy
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Apply physical therapy to eye area for 10 minutes once a day for 2 weeks
Interventions/Control_2	Apply placebo to eye area for 10 minutes once a day for 2 weeks
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	69 years-old >=
Gender	Male and Female
Key inclusion criteria	People with any persistent eye discomfort associated with prolonged VDT use (6 hours or more per day)
Key exclusion criteria	People with any disease in eyes (infectious conjunctivitis, allergic disease, autoimmune disease, collagen disease and seborrheic MGD) or people with any disease at skin around eyes (trauma, swelling and eczema)
Target sample size	60

Research contact person
Name of lead principal investigator	Ching-Hsi Hsiao
Organization	Chang Gung Memorial HospitalLinkou
Division name	Ophthalmology Department
Address	No. 5, Fuxing St., Guishan Dist., Taoyuan City 333, Taiwan
TEL	+886-2-27135211
Email	hsiao.chinghsi@gmail.com

Public contact
Name of contact person	Kyoko Tagami
Organization	Kao Corporation
Division name	R&D - Personal Health Care Research
Address	2-1-3, Bunka, Sumida-ku, Tokyo
TEL	03-5630-7271
Homepage URL
Email	tagami.kyouko@kao.co.jp

Sponsor
Institute	Kao Corporation
Institute
Department

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 15 Day
Anticipated trial start date	2016 Year 01 Month 19 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	2016 Year 10 Month 17 Day
Last modified on	2016 Year 10 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028129