UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The randomized duble blind parallel-group comparison test of the effect for eyestrain of the Bilberry extracts
Title of the study (Brief title)	The test of the effect for eyestrain of the Bilberry extracts
Region	Japan

Condition
Condition	eyestrain
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficiency for eyestrain of the foods including bilberry extracts
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Near-reflex: intake 0,4,8,12 weeks
Key secondary outcomes	Subjective symptoms: intake 0, 2, 4, 6, 8, 10, 12 weeks Eyestrain questionnaires: intake 0, 4, 8, 12 weeks Safety(blood test, urinary test, history taking):intake 0, 12 weeks

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Food
Interventions/Control_1	Bilberry extract 240mg/day, 12weeks
Interventions/Control_2	Placebo, 12weeks
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, Aged=>20 years,Male and female 2, Japanese male and female 3, PC work or driving 5 hours or more a day 4, Visual acuity with the naked eyes is 0.1 or more
Key exclusion criteria	1, Subjects who have previous medical history and/or current medical history of serious diseases (e.g., digestive organ, liver, pancreas, heart and/or kidney). 2, Subjects who take medicines. 3, Subjects who have an eye disease. 4, Subjects who have previous medical history of drug and/or food allergy. 5, Subjects who have previous medical history and/or current medical history of drug dependence and/or drug abuse. 6, Subjects who work time is irregular. 7, Subjects who have undergone LASIK. 8, Subjects who are using the reading glasses. 9, Subjects who constantly use supplements containing bilberry extract and/or functional foods or drug affecting eyestrain. 10, Subjects who have been enrolled in the other clinical trials within about last 1 month. 11, Subjects who is during pregnancy, lactation and/or wish to become pregnant in clinical test. 12, Subjects who have taken over 200 mL of blood within the last one month prior to the current study. 13, Subjects who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	120

Research contact person
Name of lead principal investigator	Marie Kosehira
Organization	Omnica Co.,Ltd
Division name	Research team
Address	TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL	03-5840-9811
Email	kosehira@omnica.co.jp

Public contact
Name of contact person	Marie Kosehira
Organization	Omnica Co.,Ltd
Division name	Research team
Address	TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL	03-5840-9811
Homepage URL
Email	kosehira@omnica.co.jp

Sponsor
Institute	HUMA R&D Co.
Institute
Department

Funding Source
Organization	Omnica Co.,Ltd
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	2016 Year 02 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 12 Day
Anticipated trial start date	2016 Year 02 Month 04 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	2016 Year 02 Month 03 Day
Last modified on	2017 Year 02 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024082