UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of bilberry extract supplement against VDT on eye fatigue: a double-blind, randomized placebo-controlled and parallel study
Title of the study (Brief title)	Effect of bilberry extract supplement against VDT on eye fatigue
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of the test food to improve of visual fatigue caused by visual display terminals (VDT) in healthy Japanese adults
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Miosis frequency (at 0 week and 6 weeks after) * Perform the test before and after VDT for 60 minutes
Key secondary outcomes	1. Flicker test (at 0 week and 6 weeks after) * Perform the test before and after VDT for 60 minutes 2. Subjective symptoms (at 0 week and 6 weeks after) * Perform the test before and after VDT for 60 minutes 3. Schirmer's test (at 0 week and 6 weeks after)

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	Treatment
Type of intervention	Food
Interventions/Control_1	Ingest 120 mg bilberry extract supplements per day for 6 weeks
Interventions/Control_2	Ingest placebo supplements for 6 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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Healthy Japanese adults 2. Persons who are aware of visual fatigue 3. Persons who usually play TV games, use PC, use Smartphone, or perform VDT for more than 4 hours a day. 4. Persons who corrected visual acuity in both eyes is >= 1.0, and who do not wear contact lenses or switch to glasses from contact lenses during the study.
Key exclusion criteria	1. Persons who have previous medical history of malignant tumor, heart failure or myocardial infarction 2. Patients who are currently under the treatment for either atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Patients who were diagnosed as presbyopia or are aware of presbyopia 4. Patients who have eye disease such as entropion or trichiasis 5. Patients who have uncorrected refractive errors 6. Patients who have severe astigmatism 7. Patients who have cause of visual fatigue except regulatory function such as nerve function, etc. 8. Persons who usually take pharmaceuticals (include herbal medicine), health-promoting diet and health food for the purpose of health maintenance 9. Persons who are allergic to medicines or foods related to the test food of this trial 10. Persons who are pregnant, lactating, or planning to get pregnant during the trial period 11. Persons who were enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial 12. Persons who are judged unsuitable for participating in this trial by physician
Target sample size	20

Research contact person
Name of lead principal investigator	Kazuo YAMAMOTO
Organization	ORTHOMEDICO, Inc.
Division name	R&D Department
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	Naoko SUZUKI
Organization	ORTHOMEDICO, Inc.
Division name	R&D Department
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO, Inc.
Institute
Department

Funding Source
Organization	TOKIWA PHYTOCHEMICAL CO., LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Seishin-kai Medical Association Inc, Takara Medical Clinic.
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	アリオ西新井クリニック眼科 (東京都) Ario Nishiarai Eye Clinic (Tokyo)

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 14 Day
Anticipated trial start date	2016 Year 03 Month 26 Day
Last follow-up date	2016 Year 07 Month 29 Day
Date of closure to data entry	2016 Year 07 Month 29 Day
Date trial data considered complete	2016 Year 07 Month 29 Day
Date analysis concluded	2016 Year 07 Month 29 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Nakata A, Yamashita S, Suzuki N, Liang T, Yang J, Yamada T. The Improvement Effect of Bilberry Extract (BILBERON)-Containing Diet on Eye Fatigue and Eye Dryness -A Randomized, Double-blind, Placebo-controlled Parallel-group Comparison Study-. Jpn Pharmacol Ther. 2016; 44(12): 1773-1783.
Other related information

Management information
Registered date	2016 Year 03 Month 25 Day
Last modified on	2017 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024927