UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058557 |
|---|---|
| Receipt number | R000066956 |
| Scientific Title | Effects of consumption of the test food on eye moisture in healthy Adults.: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2025/07/22 |
| Last modified on | 2025/07/22 18:48:51 |
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Basic information
Public title
Effects of consumption of the test food on eye moisture in healthy adults.
Acronym
Effects of consumption of the test food on eye moisture in healthy Adults
Scientific Title
Effects of consumption of the test food on eye moisture in healthy Adults.: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the test food on eye moisture in healthy Adults.
Region
| Japan |
Condition
Condition
Healthy adults.
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on eye moisture in healthy Adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured value of binocular lacrimal secretion volume at four weeks after intervention (4w) [Before-after visual display terminals (VDT) workload: the change from before to after VDT workload]
Key secondary outcomes
1. The measured value of binocular lacrimal secretion volume at two weeks after intervention (2w) [Before-after VDT workload]
2. The changes and percentage change of binocular lacrimal secretion volume at 2w and 4w from screening (Scr) [Before-after VDT workload]
3. The measured values of dominant eye lacrimal secretion and non-dominant eye lacrimal secretion at 2w and 4w, as well as their changes and percentage changes from Scr [Before VDT workload, after VDT workload, and before-after VDT workload]
4. The measured values of eye dryness, eye strain, glare, itchy eyes, visual field narrowness, neck stiffness, shoulder stiffness, and lower back stiffness (visual analogue scale; VAS) at 2w and 4w, as well as their changes and percentage changes from Scr [Before VDT workload, after VDT workload, before-after VDT workload]
5. The measured values of QOL score, ocular symptoms, and impact on daily life in the Dry Eye related Quality of life Score (DEQS) at 2w and 4w, as well as their changes and percentage changes from Scr
6. Individuals whose responses to each item in the DEQS improved by one or more scales at 2w and 4w compared to Scr
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: Four weeks
Test product: Flavonoid.
Interventions/Control_2
Duration: Four weeks
Test product: Placebo
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Adults
4. Healthy individuals
5. Individuals whose monocular visual acuity is 1.0 or better with the unaided eye or corrected eye (whichever is worse)
6. Individuals who do not wear contact lenses or who wear contact lenses but can change to glasses during this study (between the date of consent and the final examination)
7. Individuals who frequently engage in VDT work and are aware of a sensation of eye dryness
8. Individuals whose Break Up Time (BUT) exceeds five seconds at Scr
9. Individuals whose lacrimal secretion after VDT workload at Scr is less than that before VDT workload
Key exclusion criteria
1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator
3. Individuals who are undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who are diagnosed with presbyopia, or have presbyopia in self-knowledge
5. Individuals who have eye disease, entropion, or trichiasis
6. Individuals who are diagnosed with dry eye
7. Individuals with Sjogren's syndrome
8. Individuals with meibomian gland dysfunction
9. Individuals who apply eye drops for eye diseases
10. Individuals who have ametropia and have not been properly corrected
11. Individuals who have undergone laser in situ keratomileusis surgery
12. Individuals with severe astigmatism
13. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
14. Individuals who are taking or using medications (including herbal medicines) or supplements
15. Individuals who are allergic to medicines or foods related to the test product
16. Individuals with irregular sleeping duration or patterns due to night shifts or similar work, or with irregular lifestyles
17. Individuals who currently smoke or began smoking cessation within three months before providing informed consent
18. Individuals who habitually drink >= 60 g/day of alcohol
19. Individuals who are pregnant, lactating, or planning to become pregnant during this study
20. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
21. Individuals who are judged as ineligible to participate in this study by the physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Yamada |
Organization
Nishi-Arai Ekimae Clinic Ophthalmology and Orthopedics
Division name
Director
Zip code
123-0843
Address
2F Nakazato Bldg., 2-3-13, Nishi-arai sakae-cho, Adachi-ku, Tokyo, Japan
TEL
03-5681-1133
dr_yamada@orthomedico.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
Toyo Sugar Refining Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Toyo Sugar Refining 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
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
西新井駅前クリニック眼科整形外科 (東京都)
Nishi-Arai Ekimae Clinic Ophthalmology and Orthopedics (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 22 | Day |
Last modified on
| 2025 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066956
