UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015329
Receipt number R000017824
Scientific Title Effect of bilberry extract on eye function: a randomized, double blind, placebo-controlled study
Date of disclosure of the study information 2014/10/03
Last modified on 2015/04/06 13:08:42

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Basic information

Public title

Effect of bilberry extract on eye function: a randomized, double blind, placebo-controlled study

Acronym

Effect of bilberry extract on eye function

Scientific Title

Effect of bilberry extract on eye function: a randomized, double blind, placebo-controlled study

Scientific Title:Acronym

Effect of bilberry extract on eye function

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to evaluate the effects of ingestion of bilberry extract for 12 consecutive weeks on eye symptom (in relation to eye fatigue, dry eye).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

The scores and the total score of eye fatigue and dry eye symptoms of each questionnaire, in variation of before and after of VDT load

Key secondary outcomes

NEI VFQ-25, Scores and total score of eye fatigue and dry eye symptoms of each questionnaire of before or after of VDT load


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of bilberry extract for 12 weeks

Interventions/Control_2

Ingestion of placebo without bilberry extract for 12 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

65 years-old >

Gender

Male and Female

Key inclusion criteria

(1) Males and females from 20 to 64 years of age
(2) Visual display terminal (VDT) user
(3) Subjects with eye strain and eye dryness by VDT load

Key exclusion criteria

(1) Subjects who have history of the organic eye disease (e.g., cataract, glaucoma, diabetic retinopathy, and age-related macular degeneration)
(2) Subject who are under medication for eye disease (e.g., eye fatigue and dry eye)
(3) Subjects who have history of the autoimmune disease (e.g., Sjogren syndrome, Basedow's disease, Hashimoto's disease, rheumatoid arthritis)
(4) Subjects who have a severe ametropia form result of screening test.
(5) Strabismus
(6) Subjects who routinely use quasi-drug, medicine, and/or health food containing bilberry extract.
(7) Subjects who use eye drops (including behind-the-counter medicine) more than 4 days in a week (excluding artificial tears (e.g., Soft santear, artificial tear Mytear eye drop, and Mytear dry mini)
(8) Subjects who routinely take health foods (e.g., lutein, zeaxanthin, multi-vitamins, multi-mineral, omega-3 fatty acids (DHA and EPA)), quasi-drug, or medicine related to eye wellness / or take them a month before start of this study
(9) Subjects who have history or plan in study period to take punctual plug and punctual closing surgery
(10) Subjects who have history of ophthalmic surgery (including LASIK) within 3 months before start of study or have a schedule of ophthalmic surgery in study period
(11) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(12) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(13) Subjects who can't carry out the VDT loading test during study period
(14) Subjects who have possibility of allergy symptoms onset
(15) Subject who are under treatment or have a history of needing medical treatment
(16) Subjects who plan to go overseas more than one week during study period
(17) Subjects who have participated in other clinical study
(18) Subjects who are judged as unsuitable for the study by physician for any other reasons

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mika Namiki

Organization

Yaesu Sakuradori Clinic

Division name

doctor

Zip code


Address

1-6-6 yaesu, chuo-ku, Tokyo, Japan

TEL

03-6214-1285

Email

m-namiki@y-sakuradoori.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshiki Shimizu

Organization

TTC Co.,Ltd.

Division name

Clinical Research Planning Department

Zip code


Address

1-20-1 Ebisunishi, Shibuya-ku, Tokyo, Japan

TEL

03-5459-5329

Homepage URL


Email

ttcpwr2001@ttc-tokyo.co.jp


Sponsor or person

Institute

TTC Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

WAKASA SEIKATSU Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 03 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 09 Month 10 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 04 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

2014 Year 10 Month 02 Day

Last modified on

2015 Year 04 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017824


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name