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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037039
Receipt No. R000042141
Scientific Title Effects of consumption of the test food on eye functions: A randomized double-blind placebo-controlled trial
Date of disclosure of the study information 2019/06/12
Last modified on 2020/08/24

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Basic information
Public title Effects of consumption of the test food on eye functions
Acronym Effects of consumption of the test food on eye functions
Scientific Title Effects of consumption of the test food on eye functions: A randomized double-blind placebo-controlled trial
Scientific Title:Acronym Effects of consumption of the test food on eye functions
Region
Japan

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

Objectives
Narrative objectives1 To verify the effects of consumption of the test food for 6 weeks on eye functions in healthy Japanese subjects.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Percentage of pupillary response (average of both eyes)

*Compare the amount of change between before and after VDT load on between two groups at screening (before consumption) and 6 weeks after consumption
Key secondary outcomes 1. Percentage of pupillary response
1-1. average of both eyes
1-2. dominant eye
1-3. non-dominant eye

2. BUT (tear film break-up time)
2-1. average of both eyes
2-2. dominant eye
2-3. non-dominant eye

3. Schirmer's test
3-1. average of both eyes
3-2. dominant eye
3-3. non-dominant eye

4. Muscle hardness

5. Questionnaire (the Likert scale)

*1-1Assess at screening (before consumption) and 6 weeks after consumption, and compare between two groups for the measured values at before and after VDT load.
*1-2, 1-3, 4, 5 Assess at screening (before consumption) and 6 weeks after consumption, and compare between two groups for the measured values at before and after VDT load, and the amount of change between before and after VDT load.
*2, 3 Compare the measured values on between two groups at screening (before consumption) and 6 weeks after consumption.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 6 weeks
Test food: Test capsule A
Administration: Take 1 capsule with water once a day after breakfast

* If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2 Duration: 6 weeks
Test food: Placebo
Administration: Take 1 capsule with water once a day after breakfast

* If you forget to take the test food, 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 adult subjects

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 physician

5. 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. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Subjects who were diagnosed as presbyopia or are aware of presbyopia

5. Subjects who have eye diseases, entropion or trichiasis
6. Subjects who use eye drops for treatment of eye diseases

7. Subjects who have ametropia and do not be treated orthoptics properly

8. Subjects who were treated with LASIK

9. Subjects who are strong astigmatism

10. Subjects who are experiencing eye fatigue causing by nerve function and others (except accommodative function)

11. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily

12. Currently taking medicines (include herbal medicines) and supplements

13. Subjects who are allergic to medicines and/or the test food related products

14. Subjects who are pregnant, breast-feeding, and planning to become pregnant

15. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial

16. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kazuo
Middle name
Last name YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name CEO
Zip code 112-0002
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 Naoko
Middle name
Last name SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code 112-0002
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 BGG Japan Co., Ltd.
Arysta Health and Nutrition Sciences Corp.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Ario Nishiarai Eye Clinic
Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address 9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel 03-5793-3623
Email info@takara-clinic.com

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)

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 12 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 32
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
2019 Year 05 Month 27 Day
Date of IRB
2019 Year 05 Month 27 Day
Anticipated trial start date
2019 Year 06 Month 13 Day
Last follow-up date
2020 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 12 Day
Last modified on
2020 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042141

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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