UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055841 |
|---|---|
| Receipt number | R000063569 |
| Scientific Title | Evaluation test for improvement of eye fatigue by single intake of test food. |
| Date of disclosure of the study information | 2025/10/16 |
| Last modified on | 2024/11/18 13:37:10 |
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Basic information
Public title
Evaluation test for improvement of eye fatigue by single intake of test food.
Acronym
Evaluation test for improvement of eye fatigue by single intake of test food.
Scientific Title
Evaluation test for improvement of eye fatigue by single intake of test food.
Scientific Title:Acronym
Evaluation test for improvement of eye fatigue by single intake of test food.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effect of a single intake of the test food on ocular fatigue.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analogue Scale
(Observation period I and II : before and after loading)
Key secondary outcomes
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
[1] Oral ingestion of a test food (1 tablet).
[2] Observation.
[3] Oral ingestion of a placebo food (1 tablet).
[4] Observation.
Interventions/Control_2
[1] Oral ingestion of a placebo food (1 tablet).
[2] Observation.
[3] Oral ingestion of a test food (1 tablet).
[4] Observation.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Japanese males and females aged 20-64 years.
2) Individuals who are healthy and are not received treatment of disease.
3) Individuals who feel eye fatigue and thirst
4) Individuals who have binocular vision of 0.7 or better with naked eye or corrected vision, and who do not wear contact lenses.
5) Individuals whose written informed consent has been obtained.
6) Individuals who can come to the designated venue for this study and be inspected.
7) Individuals judged appropriate for the study by the principal.
Key exclusion criteria
1)Individuals using medical products.
2)Individuals with a confirmed diagnosis of dry eye or suspected dry eye.
3)Individuals who are using eye drops for the treatment of ocular diseases.
4)Individuals who have been diagnosed with presbyopia or are aware of presbyopia.
5)Individuals with eye diseases, entropion, or trichiasis.
6)Individuals who have a history of LASIK vision restoration surgery or intraocular lens surgery.
7)Individuals who use artificial tears more than 6 times a day in everyday life.
8)Individuals who regularly use contact lenses to correct their vision.
9)Individuals with a history or current history of mental illness, sleep disorders, hypertension, diabetes, dyslipidemia, eye disease or serious illness.
10)Individuals with a serious or current medical history of liver, kidney, heart, lung, blood, etc.
11)Individuals who are a patient or have a history of or endocrine disease.
12)Individuals who used a drug to treat a disease in the past 1 month.
13)Individuals with drug and food allergies.
14)Individuals who are a smoker.
15)Individuals who are currently, or within the past 3 months have been, in the habit of continuously consuming functional foods, health foods, or supplements containing lactobacilli or claiming visual function, and those who plan to consume such foods during the study period.
16)Individuals who excessively take alcohol (60 g/day in pure alcohol equivalent).
17)Individuals who may change their lifestyle during the examination period.
18)Individuals who have difficulty in inputting text in English using a personal computer and persons who can easily input text using a personal computer.
19)Individuals who engage in a night work.
20)Individuals who are or are possibly pregnant, or are lactating.
21)Individuals who participated in other clinical studies in the past 3 months.
22)Individuals who are or whose family is engaged in healthy or functional foods.
23)Individuals judged inappropriate for the study by the principal.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakajima |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinic
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & Innovations, 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.co.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
| 2025 | Year | 10 | Month | 16 | 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
| 2024 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 15 | Day |
Last modified on
| 2024 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063569
