UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of test supplement on eye strain: A randomized, double blinded, placebo controlled, and parallel group comparison study
Title of the study (Brief title)	Effect of test supplement on eye strain
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to verify the effect of test supplement on eye strain.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The scores of questionnaire on eye strain, in variation of before and after of VDT load
Key secondary outcomes	The scores of questionnaire on eye strain before VDT load, The scores of questionnaire on eye strain after VDT load, DEQS, Tear breakup time, Corneal Fluorescein Staining Pattern, Schirmer's test 1 Subgroup analysis using scores of questionnaire and other measurements

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of test supplement for 4 consecutive weeks
Interventions/Control_2	Ingestion of placebo for 4 consecutive 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	45 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Subjects aged from 45 to 65 years old (2) Subjects with eye strain by VDT load
Key exclusion criteria	(1)Subjects who have amblyopia or strabismus (2) Subjects who have history of the organic eye disease (e.g., cataract, glaucoma, diabetic retinopathy, and age-related macular degeneration) (3)Subjects who are under medication and/or medical treatment for eye disease (e.g., asthenopia and dry eye) (4)Subjects who have history of the autoimmune disease (e.g., Sjogren syndrome, Basedow's disease, Hashimoto's disease, rheumatoid arthritis) (5)Subjects who have a severe ametropia from result of screening test (6)Subjects who use eye drops (including over-the-counter medicine) more than 4 days in a week (excluding artificial tears type eye drop (e.g., Soft santear, artificial tear Mytear eye drop) (7)Subjects who routinely take food with health claim or health foods, quasi-drug, or medicine related to eye wellness / or take them a month before start of this study (8)Subjects who have history or plan in study period to take punctual plug and punctual closing surgery (9)Subjects who have history of ophthalmic surgery (including LASIK) within a year before start of study or have a schedule of ophthalmic surgery in study period (10)Subjects who have suffering from any disease or who with a case history of a serious disease that needed medication (11)Subjects who have possibilities for emerging allergy related to the study (12)Subjects who can't carry out the VDT loading test during study period (13)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (14)Subjects who have under treatment or a history of serious disease (15)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on baseline examination (16)Subjects who intend to become pregnant or lactating (17)Subjects who have participated in other clinical study (18)Subjects who are judged as unsuitable by doctor for other reasons
Target sample size	60

Research contact person
Name of lead principal investigator	Kei Yui
Organization	FANCL Corporation
Division name	Research Institute, Health science research center
Address	12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL	045-820-3755
Email	ke-yui@fancl.co.jp

Public contact
Name of contact person	Hiroyasu Shimada
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Address	1-20-2, Ebisu-nishi, Shibuya-ku, Tokyo, Japan
TEL	03-5459-5329
Homepage URL
Email	h.shimada@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd.
Institute
Department

Funding Source
Organization	FANCL Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	2018 Year 06 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 06 Month 14 Day
Anticipated trial start date	2018 Year 06 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 06 Month 22 Day
Last modified on	2018 Year 12 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037744