UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047328 |
|---|---|
| Receipt number | R000053946 |
| Scientific Title | A confirmatory study on the effect of continuous intake of test foods on eye functions and QOL. -A placebo-controlled, randomized, double-blind clinical trial- |
| Date of disclosure of the study information | 2023/08/07 |
| Last modified on | 2024/05/20 15:45:39 |
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Basic information
Public title
A confirmatory study on the effect of continuous intake of test foods on eye functions and QOL. -A placebo-controlled, randomized, double-blind clinical trial-
Acronym
A confirmatory study on the effect of continuous intake of test foods on eye functions and QOL
Scientific Title
A confirmatory study on the effect of continuous intake of test foods on eye functions and QOL. -A placebo-controlled, randomized, double-blind clinical trial-
Scientific Title:Acronym
A confirmatory study on the effect of continuous intake of test foods on eye functions and QOL
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effectiveness of continuous intake of test foods for 12-weeks on eye dryness or eye fatigue in healthy males and females who have regular awareness of eye dryness or eye fatigue due to aging or lifestyle (such as digitalization, air conditioner, or pollution of the environment) aged between 40 and less than 70 years old.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of Ocular Surface Disease Index (J-OSDI)
Dry Eye related Quality of life Score (DEQS)
Tear film break-up time (BUT) measurement
Schirmer test
Key secondary outcomes
Accommodation of eye
Subjective questionnaires
Computer Vision Syndrome Score
Total cholesterol
HDL-C
LDL-C
Blood cortisol
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
Take four capsules of the test food with water once a day.
Interventions/Control_2
Take four capsules of the placebo food with water once a day.
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Aged between 40 and less than 70 years old.
2. Japanese males and females.
3. BMI less than 30.0 kg/m^2.
4. Have awareness of eye dryness or eye fatigue.
5. Have not to use contact lenses, or have switched contact lenses to glasses 2 weeks before the day of the screening visit and also will not be using contact lenses during the study.
6. Can use smartphones or PCs to input an electronic diary.
7. Received sufficient explanation for the objective and summary of the study, and voluntarily volunteered to the study with the agreement of informed consent.
Key exclusion criteria
1. Currently undergoing treatment for any disease, or receive medical treatment such as medical drugs or traditional Chinese medicines. Medications used as needed are acceptable.
2. Currently undergoing treatment for eye diseases.
3. Receiving nutritional and exercise therapy by medical doctors.
4. Have been received any eye surgery within one year before the day of the screening visit, or planning to receive any eye surgery during the study.
5. Used any eye drops, including OTC drugs within 2 weeks before the day of the screening visit.
6. Have any severe disease or any severe symptoms, or history of severe diseases, or will be unavoidably using any eye drop, including OTC drugs during the study.
7. Have pollinosis or allergic conjunctivitis.
8. Have been taking yogurts or lactic fermenting beverages. However, can discontinue taking these foods during the study is acceptable to join the study.
9. Have been taking foods with any functional claims containing DHA, EPA, or astaxanthin more than once a week.
10. Have been taking foods with functional claims for eye health (such as blueberry, purple sweet potato) more than once a week.
11. Have been taking fish or fish eggs more than four times a week.
12. Have regularly been taking commercially available drugs, quasi-drug products, foods, or supplements with any functional claims.
13. Have allergies to drugs or foods.
14. Planning extremely change lifestyle (such as diet, sleep, or exercise) during the study.
15. Currently pregnant or breastfeeding, or planning to pregnant during the study.
16. Shift workers.
17. Individuals who joined other clinical trials from one month before the trial, individuals who have currently been joined other clinical trials, and also Individuals who are planning to join other clinical trials during the study.
18. Unsuitable for the study, that judged by the principal investigator.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Takada |
Organization
ONO PHARMACEUTICAL CO., LTD.
Division name
Business Design Department
Zip code
5418564
Address
8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka
TEL
06-6263-2924
y.takada@ono.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co, Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
Daiwaginza Bld.3F, 6-2-1, Ginza, Chuo-ku, Tokyo, Japan
TEL
03-6704-5968
Homepage URL
https://imeqrd.co.jp/
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL 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,Tokyo
Tel
03-6704-5968
jimukyoku@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
| 2023 | Year | 08 | Month | 07 | 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
| 2022 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 30 | Day |
Last modified on
| 2024 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053946
