UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008766 |
|---|---|
| Receipt number | R000010304 |
| Scientific Title | Effects of bilberry extract-containing dietary supplement on eye fatigue in VDT workers : double-blind, randomized, placebo controlled trial |
| Date of disclosure of the study information | 2012/08/24 |
| Last modified on | 2013/03/25 16:32:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of bilberry extract-containing dietary supplement on eye fatigue in VDT workers : double-blind, randomized, placebo controlled trial
Acronym
Effects of bilberry extract on eye fatigue
Scientific Title
Effects of bilberry extract-containing dietary supplement on eye fatigue in VDT workers : double-blind, randomized, placebo controlled trial
Scientific Title:Acronym
Effects of bilberry extract on eye fatigue
Region
| Japan |
Condition
Condition
Eye fatigue, dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of bilberry extract on eye fatigue
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Critical flicker frequency, near point distance (amplitude of accommodation)
Key secondary outcomes
Contrast sensitivity, functional visual acuity, BUT, keratconjunctival disorder, amount of lacrimal fluid storage (strip meniscometry), questionnaire
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
Dietary supplement containing
bilberry extract
Interventions/Control_2
Placebo without containing
bilberry extract
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Workers using visual display terminal
2) Subjects with subjective eye fatigue
3) Subjects with lowered critical flicker frequency and lowered near point distance
Key exclusion criteria
1) Corrected visual acuity < 1.0
2) High myopia
3) Routine use of bilberry extract, -enriched food or medicines with visual function-improving activity
4) Ophthalmic disorder and/or a history of severe ophthalmic disorder
5) Strabismus
6) Previous visual dysfunction due to cataract (congenital, senile, diabetic, complicated or traumatic) or glaucoma (chronic, acute, congenital, secondary)
7) A risk for developing pollinosis between July and December
8) Under medical treatment, or a history serious disease needing medical treatment
9) Lasik operation undergone within 3 month
10) Allergy to study diet
11) Participation in other clinical trial within a month
12) Expecting a pregnancy or lactation during the study period
13) Judged as unsuitable for the study based on the results of questionnaire
14) Judged to be excluded from the study by the investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Tsubota |
Organization
Keio University
Division name
School of Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
TTC Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
Address
TEL
Homepage URL
e.yamamoto@ttc-tokyo.co.jp
Sponsor or person
Institute
ShinYokohama shinoharaguchi orthopedic surgery/ dermatology,
Medical Corporation Jico-kai Yagi Hospital
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
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
| 2012 | Year | 08 | Month | 24 | 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
| 2012 | Year | 08 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 25 | 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
| 2012 | Year | 08 | Month | 24 | Day |
Last modified on
| 2013 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010304
