UMIN-CTR Clinical Trial

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

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

TTC Co., Ltd.

Institute

Department

Personal name

Organization

WAKASA SEIKATSU Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

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

Date of disclosure of the study information

2014

Year

10

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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