UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059589 |
|---|---|
| Receipt number | R000068072 |
| Scientific Title | Evaluation of the effects of a test food on Dry eye symptoms in healthy adults: randomized, double-blind, placebo-controlled, parallel-group comparative study |
| Date of disclosure of the study information | 2025/10/30 |
| Last modified on | 2025/10/30 09:22:29 |
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Basic information
Public title
Evaluation of the effects of a test food on Dry eye symptoms in healthy adults
Acronym
Evaluation of the effects of a test food on Dry eye symptoms in healthy adults
Scientific Title
Evaluation of the effects of a test food on Dry eye symptoms in healthy adults: randomized, double-blind, placebo-controlled, parallel-group comparative study
Scientific Title:Acronym
Evaluation of the effects of a test food on Dry eye symptoms in healthy adults: randomized, double-blind, placebo-controlled, parallel-group comparative study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of test food consumption on symptoms of dry eye
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Break-up time (BUT) of the tear film
Key secondary outcomes
Japanese version of the oscular surface disease index(J-OSDI)
Simple questionnaire regarding eye condition
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
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of the test food for 4 weeks
Interventions/Control_2
Intake of the placebo food for 4 weeks
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males from 20 to 64 years old.
(2) Subjects who are concerned about dry eyes.
(3) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.
Key exclusion criteria
(1) Subjects with a history of mental illness, diabetes,liver diseases, renal disease, gastrointestinal disease, cardiac disease, respiratory disease, peripheral vascular disease, or other serious disease.
(2) Subjects with a history of ocular disease or eye surgery.
(3) Subjects currently receiving ophthalmologic treatment.
(4) Subjects using anti-inflammatory eye drops (e.g., steroids, cyclosporine, lifitegrast) or anti-allergic eye drops (e.g., olopatadine, epinastine, ketotifen).
(5) Subjects taking prescription or over-the-counter medications including anticholinergics, antihistamines, antidepressants, beta-blockers, isotretinoin, etc.
(6) Subjects who wear contact lenses.
(7) Subjects with a history of gastrointestinal surgery.
(8) Subjects with abnormal liver or kidney function test results.
(9) Subjects currently undergoing treatment for any disease.
(10) Subjects who are allergic to the foods in this study.
(11) Females who are pregnant, breastfeeding, or planning to become pregnant during the study period (including those who may be pregnant).
(12) Subjects with a tear film break-up time (BUT) of 5 seconds or less.
(13) Subjects who engage in intense sports activities or are currently on a diet.
(14) Subjects with extremely irregular dietary or lifestyle habits.
(15) Subjects who cannot refrain from consuming health foods (including Foods for specified health uses, foods with functional claims, and supplements) or designated quasi-drugs during the study period.
(16) Subjects who are continuously undergoing treatment with medications (including OTC and prescription drugs).
(17) Subjects whose average daily alcohol consumption exceeds 40 g of pure alcohol.
(18) Smokers.
(19) Subjects who are currently participating in other clinical studies or are scheduled to participate in research at the start of this study.
(20) Other subjects judged by the investigator or the investigator to be inappropriate for the examination.
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Takeda |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
1820002
Address
2-5-7 Sengawacho, Chofu-shi, Tokyo
TEL
03-5384-7759
yumi_takeda@kewpie.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Terashima |
Organization
Oneness Support Co., Ltd.
Division name
Clinical Trial Division
Zip code
5300044
Address
Higashitenma building 6F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-4801-8917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corporation
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 Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
Tel
06-6135-5200
mterashima@miura-cl.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
医療法人花音会みうらクリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | 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 | 10 | Month | 30 | Day |
Last modified on
| 2025 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068072
