UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060466 |
|---|---|
| Receipt number | R000069179 |
| Scientific Title | A study to evaluate the effects of continuous consumption of the test food on visual function and QOL: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2026/01/26 |
| Last modified on | 2026/01/26 09:26:20 |
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Basic information
Public title
A study to evaluate the effects of continuous consumption of the test food on visual function and QOL
Acronym
A study to evaluate the effects of continuous consumption of the test food on visual function and QOL
Scientific Title
A study to evaluate the effects of continuous consumption of the test food on visual function and QOL: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
A study to evaluate the effects of continuous consumption of the test food on visual function and QOL
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
<Primary objective>
To evaluate the efficacy of 12-week consumption of the test food, compared with a placebo, in healthy men and women with a tendency toward ocular dryness, using lacrimal secretion volume as the indicator.
<Secondary objectives>
1. To evaluate the efficacy of 12-week consumption of the test food, compared with a placebo, in healthy men and women with a tendency toward ocular dryness, using a dryness Visual Analogue Scale (VAS), the Dry Eye related Quality of life Score (DEQS), and blood pentosidine levels as indicators.
2. To evaluate the safety of 12-week consumption of the test food, compared with a placebo, in healthy men and women with a tendency toward ocular dryness.
Basic objectives2
Safety,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 12 weeks after intervention (12w)
Key secondary outcomes
1. The measured value of blood pentosidine at 12w
2. The change and percentage change from screening (Scr) of binocular lacrimal secretion volume at 12w
3. The measured values of lacrimal secretion volume of the dominant eye and non-dominant eye; eye dryness, eye strain, glare, itchy eyes, visual field narrowness, neck stiffness, shoulder stiffness, lower back stiffness, oral dryness assessed by self-reported symptom questionnaire (VAS); and DEQS summary score, bothersome ocular symptoms, and impact on daily life at 12w, and their changes and percentage changes from Scr
4. Individuals whose responses to each item of the DEQS improved by one or more scales at 12w compared with Scr
5. Individuals who experienced adverse events
6. Individuals whose urinalysis and peripheral blood test values were within the reference range at Scr but became outside the reference range after intervention
7. Physical measurements, urinalysis, and peripheral blood test
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test product: Test food
Interventions/Control_2
Duration: 12 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Individuals aged 20 or more and less than 65
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 are aware of dry eye-like symptoms in daily life (e.g., eye strain, a gritty sensation, a feeling of dryness, or ocular discomfort)
8. Individuals with a Break Up Time (BUT) > 5 seconds in both eyes at Scr
9. Individuals with low lacrimal secretion volume at Scr
Key exclusion criteria
Individuals who
1. receive treatment or have a history of malignant tumor, heart failure, or myocardial infarction
2. have a pacemaker or an implantable cardioverter defibrillator
3. receive treatment for cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases
4. take Foods for Specified Health Uses or Foods with Functional Claims, particularly those who take or plan to take such foods or supplements that claim to improve eye-related functions
5. receive treatment for eye conditions
6. have diseases related to the lacrimal glands or Meibomian glands, such as dry eye
7. have undergone eye surgery within 1 year before Scr, or plan to undergo eye surgery during this study
8. have used eye drops, including over-the-counter (OTC), within 2 weeks before Scr
9. are unable to discontinue the use of eye drops, including OTC, during this study
10. use or plan to use cholinergic agents, anticholinergic agents, or herbal medicines used to alleviate dry eye symptoms
11. are diagnosed with presbyopia
12. have undergone laser in situ keratomileusis
13. have hay fever or allergic conjunctivitis
14. have a history or currently have drug or food allergies
15. plan to make significant changes in their lifestyle (e.g., diet, sleep, or exercise)
16. work night shifts or other rotating shifts
17. have a history or currently have dependence on alcohol, hypnotics, central analgesics, or psychotropic drugs
18. have a history or currently have psychiatric disorders
19. take medicines (including herbal medicines) or supplements
20. are pregnant, lactating, or planning to become pregnant during this study
21. have participated in other clinical studies within 28 days before informed consent, or plan to participate in another study during this study
22. are judged as ineligible to participate in this study by the physician
Target sample size
80
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
Nippon Shinyaku Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nippon Shinyaku 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
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)
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)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 26 | 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
| 2026 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 09 | 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
| 2026 | Year | 01 | Month | 26 | Day |
Last modified on
| 2026 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069179
