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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029213
Receipt No. 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 2018/04/24

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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
Institute ORTHOMEDICO Inc.
Institute
Department

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
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
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
2018 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.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


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