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 functional food including Bilberry extracts
Title of the study (Brief title)	The test of the effect for eyestrain of the functional food including Bilberry extracts
Region	Japan

Condition
Condition	Eyestrain
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to investigate the efficacy of the foods including bilberry extracts for eyestrain
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Near-reflex
Key secondary outcomes	Dry eye test, Fundus blood flow speed, Visual analog scale, Physical examinations, Blood test, Urine test and adverse event

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	control group
Interventions/Control_2	test sample1 group
Interventions/Control_3	test sample2 group
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	Subjects who are aware of eyestrain. Subjects who ageree to participate in the current study with written informed consent.
Key exclusion criteria	Subjects who have serious historical disease of ophhalmopathy or have morbidity. Subjects who daily ingest drugs or health foods which would improve eyestrain. Subjects who have serious historical disease or have morbidity, marked impairment of heart, lung,liver, kidney, heart, or gastrointestinal tract functions (excluding extirpation of vermiform appendix). Subjects suspected that accommodative asthenopia or other non-neurogenic. Pregnant and lactating female, or who wish to get pregnant during the study period. Subjects who participate in other clinical trials within the last 4 weeks prior to the current clinical trial. Subjects who are ineligible due to physician's judgment.
Target sample size	30

Research contact person
Name of lead principal investigator	Kitaichi Nobuyoshi
Organization	Health Sciences University of Hokkaido Hospital
Division name	Department of Ophthalmology
Address	Ainosato2-5, Kita-ku, Sapporo, Japan
TEL	011-775-7878
Email	nobukita@hoku-iryo-u.ac.jp

Public contact
Name of contact person	Tomita Shimpei
Organization	New drug research center, Inc.
Division name	Clinical Research Dept.
Address	452-1Toiso,Eniwa-shi,Hokkaido, Japan
TEL	0123-34-0412
Homepage URL
Email	s-tomita@ndrcenter.co.jp

Sponsor
Institute	Department of Ophthalmology , Health Sciences University of Hokkaido Hospital
Institute
Department

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

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	北海道医療大学病院（北海道）

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 12 Day
Anticipated trial start date	2014 Year 09 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2014 Year 11 Month 30 Day
Date analysis concluded

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

Management information
Registered date	2014 Year 09 Month 25 Day
Last modified on	2017 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017715