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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024437
Receipt No. R000028129
Scientific Title Research on the efficacy and safety of physical therapy in visual display terminals (VDTs) users : Kao-001
Date of disclosure of the study information 2016/10/18
Last modified on 2016/10/17

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Basic information
Public title Research on the efficacy and safety of physical therapy in visual display terminals (VDTs) users : Kao-001
Acronym Efficacy evaluation test of physical therapy in VDT users
Scientific Title Research on the efficacy and safety of physical therapy in visual display terminals (VDTs) users : Kao-001
Scientific Title:Acronym 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
1st name
Middle name
Last name Ching-Hsi Hsiao
Organization Chang Gung Memorial HospitalLinkou
Division name Ophthalmology Department
Zip code
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
1st name
Middle name
Last name Kyoko Tagami
Organization Kao Corporation
Division name R&D - Personal Health Care Research
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2015 Year 12 Month 15 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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