UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029213
Receipt number R000033388
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-
Date of disclosure of the study information 2017/09/20
Last modified on 2021/05/31 13:42:17

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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 or person

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name



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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name