UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044917 |
|---|---|
| Receipt number | R000051261 |
| Scientific Title | Study to evaluate the effect of continuous intake of test food on the decrease of focusing accommodation attributed to eye strain -Crossover study- |
| Date of disclosure of the study information | 2021/07/21 |
| Last modified on | 2023/01/31 09:35:57 |
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Basic information
Public title
Study to evaluate the effect of continuous intake of test food on the decrease of focusing accommodation attributed to eye strain
-Crossover study-
Acronym
Study to evaluate the effect of continuous intake of test food on the decrease of focusing accommodation attributed to eye strain
Scientific Title
Study to evaluate the effect of continuous intake of test food on the decrease of focusing accommodation attributed to eye strain
-Crossover study-
Scientific Title:Acronym
Study to evaluate the effect of continuous intake of test food on the decrease of focusing accommodation attributed to eye strain
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of test food, for the decrease of focusing accommodation attributed to eye strain, by ingesting test food for 4 weeks on healthy Japanese men and women aged between 25 and 40 years.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
High frequency component (HFC) change amount
Key secondary outcomes
Amplitude of accommodation
Subjective symptoms
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
Take 2 tablets of test food daily after breakfast
Interventions/Control_2
Take 2 tablets of placebo food daily after breakfast
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
| 25 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age between 25 and 40 years at the time of informed consent.
2. Japanese male or female.
3. Those who have subjective symptoms of eye strain and were determined by the principal investigator to be an suitable subject for this study.
4. Those who do VDT work more than 4 hours.
5. Those whose eyesight is over 0.7 (regardless of naked or sight correction).
6. Those who do not have eye disease except ametropia (myopia, hyperopia, astigmatism).
7. Those who do not use glasses or screen having effects of blue light cut.
8. Those who are able to input electrical diary with smartphone/PC.
9. Those who received sufficient explanation about the trial, volunteered to participate after understanding the purpose, and agree to participate in the trial with written consent.
Key exclusion criteria
1. Those who are attending a hospital or receiving treatment of medicines or Chinese medicines due to disease.
2. Those who had LASIK surgery in past.
3. Those who are receiving nutrition therapy or physical therapy under doctor's supervision.
4. Those who have a current or past medical history of severe diseases or organic eye disease.
5. Those who have entropion or trichiasis
6. Those whose measured value of astigmatometry is more than 1.25 D.
7. Those who wear eyelash extensions.
8. Those who do not have sleep enough.
9. Those who are likely to onset allergic conjunctivitis (seasonal or year-round) during this trial.
10. Those who currently and regularly use OTC medicines or quasi drugs (including eye drops), food for specified health uses, foods with functional claims, dietary supplements, or supplements.
11. Those who take yogurt or lactic acid bacteria drinks daily for health (However, except those who can quit taking them during this trial after obtaining consent).
12. Those who have current or history of drug allergies or food allergies.
13. Those who drink a lot of alcohol (60g/day alcohol conversion).
14. Those who have habit of smoking.
15. Those who are likely to change lifestyle (meal, sleep, motional activity), such as long trip, working night shift, and not able to keep certain lifestyle.
16. Those who are pregnant or lactating, or willing to be pregnant during the trial.
17. Those who had been participating in another clinical trial within one month before obtaining consent to the trial, or planning to participate during another clinical trial.
18. Those who were determined by the principal investigator to be unsuitable for this clinical test.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takayasu |
| Middle name | |
| Last name | Noguchi |
Organization
WAKAMOTO PHERMACEUTICAL CO., LTD
Division name
Health Care Development Dept.
Zip code
103-8330
Address
2-2-2, Nihonbashi Honcho, Chuo-ku, Tokyo, Japan
TEL
03-3279-0371
t.noguchi@wakamoto-pharm.co.jp
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd
Division name
Sales department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
h-kayama@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
WAKAMOTO PHERMACEUTICAL CO., 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
Suda Clinic institutional review board
Address
2-8-14, Takadanobaba, Shinjyuku-ku, Tokyo
Tel
03-6704-5968
n-yuzawa@imeqrd.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
| 2021 | Year | 07 | Month | 21 | 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
| 2021 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 20 | Day |
Last modified on
| 2023 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051261
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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