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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021611
Receipt No. R000024927
Scientific Title Effect of bilberry extract supplement against VDT on eye fatigue: a double-blind, randomized placebo-controlled and parallel study
Date of disclosure of the study information 2016/03/25
Last modified on 2017/01/30

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Basic information
Public title Effect of bilberry extract supplement against VDT on eye fatigue: a double-blind, randomized placebo-controlled and parallel study
Acronym Effect of bilberry extract supplement against VDT on eye fatigue
Scientific Title Effect of bilberry extract supplement against VDT on eye fatigue: a double-blind, randomized placebo-controlled and parallel study
Scientific Title:Acronym Effect of bilberry extract supplement against VDT on eye fatigue
Region
Japan

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

Objectives
Narrative objectives1 To investigate the effect of the test food to improve of visual fatigue caused by visual display terminals (VDT) in healthy Japanese adults
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Miosis frequency (at 0 week and 6 weeks after)
* Perform the test before and after VDT for 60 minutes
Key secondary outcomes 1. Flicker test (at 0 week and 6 weeks after)
* Perform the test before and after VDT for 60 minutes

2. Subjective symptoms (at 0 week and 6 weeks after)
* Perform the test before and after VDT for 60 minutes

3. Schirmer's test (at 0 week and 6 weeks 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 Ingest 120 mg bilberry extract supplements per day for 6 weeks
Interventions/Control_2 Ingest placebo supplements for 6 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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Healthy Japanese adults

2. Persons who are aware of visual fatigue

3. Persons who usually play TV games, use PC, use Smartphone, or perform VDT for more than 4 hours a day.

4. Persons who corrected visual acuity in both eyes is >= 1.0, and who do not wear contact lenses or switch to glasses from contact lenses during the study.
Key exclusion criteria 1. Persons who have previous medical history of malignant tumor, heart failure or myocardial infarction

2. Patients who are currently under the treatment for either atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases

3. Patients who were diagnosed as presbyopia or are aware of presbyopia

4. Patients who have eye disease such as entropion or trichiasis

5. Patients who have uncorrected refractive errors

6. Patients who have severe astigmatism

7. Patients who have cause of visual fatigue except regulatory function such as nerve function, etc.

8. Persons who usually take pharmaceuticals (include herbal medicine), health-promoting diet and health food for the purpose of health maintenance

9. Persons who are allergic to medicines or foods related to the test food of this trial

10. Persons who are pregnant, lactating, or planning to get pregnant during the trial period

11. Persons who were enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial

12. Persons who are judged unsuitable for participating in this trial by physician
Target sample size 20

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

Sponsor
Institute ORTHOMEDICO, Inc.
Institute
Department

Funding Source
Organization TOKIWA PHYTOCHEMICAL CO., LTD
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Seishin-kai Medical Association Inc, Takara Medical 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)

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 25 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Nakata A, Yamashita S, Suzuki N, Liang T, Yang J, Yamada T. The Improvement Effect of Bilberry Extract (BILBERON)-Containing Diet on Eye Fatigue and Eye Dryness -A Randomized, Double-blind, Placebo-controlled Parallel-group Comparison Study-. Jpn Pharmacol Ther. 2016; 44(12): 1773-1783.
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
2016 Year 03 Month 14 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 26 Day
Last follow-up date
2016 Year 07 Month 29 Day
Date of closure to data entry
2016 Year 07 Month 29 Day
Date trial data considered complete
2016 Year 07 Month 29 Day
Date analysis concluded
2016 Year 07 Month 29 Day

Other
Other related information

Management information
Registered date
2016 Year 03 Month 25 Day
Last modified on
2017 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024927

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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