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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035790
Receipt No. R000040771
Scientific Title Effect of the supplement on accommodation of eye in middle- and old-aged adults : A randomized, double blinded, placebo controlled, and parallel group comparison study.
Date of disclosure of the study information 2019/02/07
Last modified on 2019/03/18

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Basic information
Public title Effect of the supplement on accommodation of eye in middle- and old-aged adults : A randomized, double blinded, placebo controlled, and parallel group comparison study.
Acronym Effect of supplement on accommodation of eye.
Scientific Title Effect of the supplement on accommodation of eye in middle- and old-aged adults : A randomized, double blinded, placebo controlled, and parallel group comparison study.
Scientific Title:Acronym Effect of supplement on accommodation of eye.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate the improvement of accommodation of eye in middle and old-aged adults who are perceiving eye fatigue after administration of supplement for 4 weeks.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Accommodation of eye (4 weeks after ingestion)
Key secondary outcomes

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 Ingestion of test food for 4 weeks
Interventions/Control_2 Ingestion of placebo for 4 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
35 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1. From 35 to 64 years old
2. Binocular vision is more than 1.0 at naked or corrected eyesight . The specifications of eye-contact lens or glasses cannot be changed and replaced with new ones during the test period.
3. Have no eye diseases other than refractive error (near-sightedness, far-sightedness and astigmatism)
4. Near point distance is lower than the age average.
5. The person who can go to facilities on check days
6.Written informed consent
Key exclusion criteria 1. Risk of onset of pollen allergy during the study period (February to April)
2. Conduct of lasik surgery during the past 6 months
3. Presence or history of hepatitis diseases or severe renal, endocrine, cardiovascular, gastric, lung, hematologic and metabolic disorder diseases
4. Current medications (excluding on-demand use)
5. Can't stop to take a supplement during the study period.
6. Presence or history of drug/food allergy
7. Receipt of investigational product in other clinical studies during the past one month or currently participating in other clinical studies
8. Female who is pregnant, breast-feeding or intends to become pregnant
9. Patients whom principal investigator judges inappropriate to invite to this study
Target sample size 40

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kei Yui
Organization FANCL Corporation
Division name Research Institute, Health science research center
Zip code
Address 12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL 045-820-3755
Email ke-yui@fancl.co.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Shimpei Tomita
Organization New drug research center, Inc.
Division name R&D Center, Research Dept., Clinical Research Dept.
Zip code
Address 452-1Toiso,Eniwa-shi,Hokkaido, Japan
TEL 0123-34-0412
Homepage URL
Email s-tomita@ndrcenter.co.jp

Sponsor
Institute New Drug Research Center Inc.
Institute
Department

Funding Source
Organization FANCL Corporation
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
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 浜田山ファミリークリニック

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 07 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 No longer recruiting
Date of protocol fixation
2019 Year 02 Month 06 Day
Date of IRB
2019 Year 02 Month 04 Day
Anticipated trial start date
2019 Year 02 Month 12 Day
Last follow-up date
2019 Year 04 Month 22 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 02 Month 06 Day
Last modified on
2019 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040771

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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