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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037406
Receipt No. R000042650
Scientific Title Verification of eye fatigue suppression effect while VDT work by ingesting test foods.
Date of disclosure of the study information 2019/07/22
Last modified on 2020/01/17

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Basic information
Public title Verification of eye fatigue suppression effect by ingesting test foods.
A placebo-controlled, Simple Randomization, double blind, cross over trial.
Acronym Verification of eye fatigue suppression effect by ingesting test foods.
Scientific Title Verification of eye fatigue suppression effect while VDT work by ingesting test foods.
Scientific Title:Acronym Verification of eye fatigue suppression effect while work by ingesting foods.
Region
Japan

Condition
Condition healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verify the eye fatigue suppression effect by ingesting test foods while VDT work.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Subject's assessment of eye fatigue parameters before and after VDT work (VAS method)
Key secondary outcomes Subject's spherical equivalent refraction, accommodative amplitude and dry eye before and after VDT work

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 Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ingestion of 4 test foods during 60 minutes of VDT (PC) work (1 day)
->Ingestion of 4 control foods during 60 minutes of VDT (PC) work (1 day)
Interventions/Control_2 Ingestion of 4 control foods during 60 minutes of VDT (PC) work (1 day)
->Ingestion of 4 test foods during 60 minutes of VDT (PC) work (1 day)
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
60 years-old >
Gender Male and Female
Key inclusion criteria (1) Healthy males and females from 20 to 59 years of age
(2) Subjects feel eye fatigue while VDT work
(3) Subjects have no medical history or disease that may affect the current study
(4) Subjects have more than 40/40 vision for both eyes by naked eye or contact lens wearing
(5) Subjects are not strong myopia, hyperopia and astigmatism
(6)Subjects are not strong presbyopia
(7) Subjects giving written informed consent
Key exclusion criteria (1) Individuals who are pregnant or nursing
(2)Individuals are using supplements for eye
(3) Subjects have food (gelatin) allergy
(4) Individuals can not open their eyes for 5 seconds
(5) Subjects can not eat test foods
Target sample size 46

Research contact person
Name of lead principal investigator
1st name Ken
Middle name
Last name Asakawa
Organization School of Allied Health Sciences, Kitasato University
Division name Department of Orthoptics and Visual Science
Zip code 252-0373
Address 1-15-1 Kitasato, Sagamihara, Minami-ku, Kanagawa
TEL 042-778-9667
Email asaken@kitasato-u.ac.jp

Public contact
Name of contact person
1st name Ken
Middle name
Last name Asakawa
Organization School of Allied Health Sciences, Kitasato University
Division name Department of Orthoptics and Visual Science
Zip code 252-0373
Address 1-15-1 Kitasato, Sagamihara, Minami-ku, Kanagawa
TEL 042-778-9667
Homepage URL
Email asaken@kitasato-u.ac.jp

Sponsor
Institute School of Allied Health Sciences, Kitasato University
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization School of Allied Health Science, Kitasato University
Address 1-15-1 Kitasato, Sagamihara, Minami-ku, Kanagawa
Tel 042-778-9602
Email a-soumu@kitasato-u.ac.jp

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
2019 Year 07 Month 22 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 50
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 No longer recruiting
Date of protocol fixation
2019 Year 05 Month 21 Day
Date of IRB
2019 Year 05 Month 17 Day
Anticipated trial start date
2019 Year 07 Month 29 Day
Last follow-up date
2020 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 07 Month 18 Day
Last modified on
2020 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042650

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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