UMIN-CTR Clinical Trial

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
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
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	Completed
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	2019 Year 05 Month 31 Day
Date trial data considered complete	2019 Year 06 Month 30 Day
Date analysis concluded	2019 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 02 Month 06 Day
Last modified on	2019 Year 08 Month 10 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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