UMIN-CTR Clinical Trial

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

Healthy Japanese adults

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

YAWATA CORPORATION

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Ario Nishiarai Eye Clinic

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

アリオ西新井クリニック眼科 (東京都)
Ario Nishiarai Eye Clinic (Tokyo, Japan)

Date of disclosure of the study information

2017

Year

09

Month

20

Day

URL releasing protocol

Unpublished

Publication of results

Published

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

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 related information

Registered date

2017

Year

09

Month

20

Day

Last modified on

2021

Year

05

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033388