UMIN-CTR Clinical Trial

Basic information
Public title	A verification study for effects of supplement with bilberry extract on the eye function and condition: effects of decreasing the eye accommodative function associated with VDT load as primary outcome -A randomized double-blind, parallel-group, placebo-controlled study-
Acronym	Effects of supplement with bilberry extract on the eye function and condition
Scientific Title	A verification study for effects of supplement with bilberry extract on the eye function and condition: effects of decreasing the eye accommodative function associated with VDT load as primary outcome -A randomized double-blind, parallel-group, placebo-controlled study-
Scientific Title:Acronym	Effects of supplement with bilberry extract on the eye function and condition
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of eye fatigue by the supplement intake
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Accommodative function * Assess these at screening and examination day before consuming, and at 4, 8, and 12 weeks after consuming. Perform the test before and after 60 minutes VDT load.
Key secondary outcomes	1. Night time visual acuity test (the recovery time of light adaptation) 2. Visual Analogue Scale (VAS) of subjective symptoms *1,2 Assess these at screening and examination day before consuming, and at 4, 8, and 12 weeks after consuming *1 Perform the test before 60 minutes VDT load. *2 Perform the test before and after 60 minutes VDT load and following a 15 minutes rest 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	Duration: 12 weeks Test materials: Bilberry extract contained in capsule Dose: Take a capsule once a day (550 mg) Administration: Take a capsule after breakfast. *If you forget to take the capsule, take it as soon as you remember within the day.
Interventions/Control_2	Duration: 12 weeks Test materials: Placebo Dose: Take a capsule once a day (555 mg) Administration: Take a capsule after breakfast. *If you forget to take the capsule, take it as soon as you remember within the 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Healthy Japanese adults 2. Subjects who are experiencing eye fatigue when they work on Visual Display Terminals (VDT) operation 3. Subjects who have corrected vision of both eyes with 1.0 or more and who do not use contact lenses, or who can switch to using eye glasses during the test period 4. Subjects who are judged as eligible to participate in the study by the principal investigator 5. Among the subjects who passed 4., subjects whose percentage of pupil constriction (average of both eyes) dropped at a relatively larger rate before and after VDT load at screening and examination before ingestion
Key exclusion criteria	1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases 3. Subjects who were diagnosed as presbyopia or are aware of presbyopia 4. Subjects who have eye diseases, entropion or trichiasis 5. Subjects who use eye drops for treatment of eye diseases 6. Subjects who have ametropia and do not be treated orthoptics properly 7. Subjects who were treated with LASIK 8. Subjects who are strong astigmatism 9. Subjects who are experiencing eye fatigue causing by nerve function and others (except accommodative function) 10. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", food/beverage which effective for visual function improvement, or other functional food/beverage in daily 11. Currently taking medicines (include herbal medicines) and supplements 12. Subjects who are allergic to medicines and/or the test food related products 13. Subjects who are pregnant, breast-feeding, and planning to become pregnant 14. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 15. Subjects who are judged as ineligible to participate in the study by the principal investigator
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuo YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

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

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	YAWATA CORPORATION
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Ario Nishiarai Eye Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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, Japan)

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 20 Day

Related information
URL releasing protocol	Unpublished
Publication of results	Published

Result
URL related to results and publications	http://www.pieronline.jp/content/article/0386-3603/47030/503
Number of participants that the trial has enrolled	44
Results	Okamoto K, Kushima M, Ishii I, Yamada T. Impacts of the Intake of a Dietary Supplement Containing Bilberry Extract on Improving Eye Functions and Conditions Caused by Visual Display Terminal Load-A Randomized, Double-blind, Parallel-group, Placebo-controlled Study-. Jpn Pharmacol Ther. 2019; 47(3): 503-515
Results date posted	2021 Year 05 Month 31 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2019 Year 03 Month 28 Day
Baseline Characteristics	Refer to the paper
Participant flow	Refer to the paper
Adverse events	Refer to the paper
Outcome measures	Refer to the paper
Plan to share IPD	Undecided
IPD sharing Plan description	To require consultation among related companies

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 11 Day
Date of IRB
Anticipated trial start date	2017 Year 09 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 09 Month 20 Day
Last modified on	2021 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033388