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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040010
Receipt No. R000045567
Scientific Title A Confirmation study on the effect of VUP intake on visual function in healthy adults
Date of disclosure of the study information 2020/03/31
Last modified on 2021/02/02

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Basic information
Public title A Confirmation study on the effect of VUP intake on visual function in healthy adults
Acronym A Confirmation study on the effect of VUP intake on visual function in healthy adults
Scientific Title A Confirmation study on the effect of VUP intake on visual function in healthy adults
Scientific Title:Acronym A Confirmation study on the effect of VUP intake on visual function in healthy adults
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to examine the effects of continuous intake of VUP on visual function in healthy adults aged 20 to 40 years old.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Objective refraction
Key secondary outcomes (Secondary evaluation item)
Axis length,Subjective symptoms(VAS values),Choroid thickness,Impression questionnaire
(Safety evaluation items)
Vital signs, biochemistry tests, hematological tests, urinalysis, slit lamp, intraocular pressure tests, OCT tests (fundus), adverse events, side effects

Base
Study type Interventional

Study design
Basic design Cross-over
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 4-weeks Intake I period (test food) - washout period - Intake II period (placebo).
Interventions/Control_2 4-weeks Intake I period (placebo) - washout period - Intake II period (test food).
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)Japanese men and women between the ages of 20 and 40 at the time of obtaining consent.
2)Subject who has visual acuity of 0.7 or more in both eyes (regardless of naked eye, wearing visual acuity corrector)
3)Subject who uses video games or personal computers on a daily basis, or who perform VDT for work more than 4 hours a day.
4)Subject who has received a sufficient explanation of the purpose and contents of the research, has the consent ability, has a good. understanding, voluntarily volunteer to participate in the test, and has agreed in writing to participate in the test.
Key exclusion criteria 1)Subject with strong myopia.(myopia of -6.0D or more)
2)Subject with pathologic myopia.
3)Subject with astigmatism of +-1.50D or more.
4)Subject with eye diseases other than refractive error.
5)Subject who can't stop using eye drops(excluding artificial tears)and eye ointments including over-the-counter drugs during the test period.
6)Subject who can't stop taking health foods(including supplements)that state effects on visual function within 1 month from the start of the test food intake, or who plans to consume them during the test period.
7)Subject who has taken health foods(including supplements)containing the components involved in the test foods within 1 month from the start of the test food intake, or who plans to consume them during the test period.
8)Subject who has undergone eye surgery, including refractive surgery.
9)Subject who has worn hard contact lenses(including orthokeratology lenses)within 1 year from the start of the test food intake, or who plans to wear them during the test.
10)Subject who has changed the power of contact lenses or eyeglasses within 1 month from the start of the test food intake, or who plans to change during the test.
11)Subject who has worn multifocal or bifocal contact lenses and progressive-refractive eyeglasses within 1 month of taking the test food intake, or who will wear it during the test.
12)Subject who has an existing disease or a history of allergy for an ingredients intaking for test food.
13)Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
14)Subject who has participated in other clinical trials or clinical trials within 1 month of ingestion of the test food, or who will participate in this test period.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Daisuke
Middle name
Last name Ochitani
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code 108-0014
Address Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo Japan,108-0014
TEL 03-3431-1260
Email ochitani@huma-rd.co.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Ochitani
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code 108-0014
Address Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo Japan,108-0014
TEL 03-3431-1260
Homepage URL
Email ochitani@huma-rd.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

Funding Source
Organization ROHTO Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Hirookai Kunitachi Sakura Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization AMC Nishi-Umeda Clinic Ethical Review Committee
Address Maruito West Umeda Building 3F 3-3-45 Umeda Kita-ku Osaka Japan,530-0001
Tel 06-4797-5660
Email jimukyoku@amc-clinc.jp

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
2020 Year 03 Month 31 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 29
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
2020 Year 03 Month 26 Day
Date of IRB
2020 Year 03 Month 26 Day
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2020 Year 08 Month 07 Day
Date of closure to data entry
2020 Year 08 Month 20 Day
Date trial data considered complete
2020 Year 08 Month 24 Day
Date analysis concluded
2020 Year 12 Month 18 Day

Other
Other related information (Exclusion criteria continued)
15)Subject who is disease or history such severe diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, other metabolic diseases.
16)Subject who needs to take antiplatelet drugs and anticoagulants(warfarin,etc.)during the test period.
17)Subject who can't keep the daily records.
18)Subject who is judged as an inappropriate candidate according to the screening data.
19)Subject who is judged by the principal investigator or subinvestigator to be inappropriate as subject.

Management information
Registered date
2020 Year 03 Month 31 Day
Last modified on
2021 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045567

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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