UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024437
Receipt number 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 13:10:20

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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 or person

Institute

Kao Corporation

Institute

Department

Personal name



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

Value
https://center6.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