UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042650