UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037406 |
|---|---|
| Receipt number | 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 | 2021/01/18 09:41:02 |
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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
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
asaken@kitasato-u.ac.jp
Sponsor or person
Institute
School of Allied Health Sciences, Kitasato University
Institute
Department
Personal name
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
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
Completed
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
| 2021 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042650
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| Registered date | File name |
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