Unique ID issued by UMIN | UMIN000033448 |
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Receipt number | R000038141 |
Scientific Title | Investigateion of improvement of accommodation of eye for middle and old-aged adults : A randomized, double blinded, placebo controlled, and parallel group comparison study. |
Date of disclosure of the study information | 2018/07/19 |
Last modified on | 2019/08/10 13:15:42 |
Investigateion of improvement of accommodation of eye for middle and old-aged adults : A randomized, double blinded, placebo controlled, and parallel group comparison study.
Effect of supplement on accommodation of eye.
Investigateion of improvement of accommodation of eye for middle and old-aged adults : A randomized, double blinded, placebo controlled, and parallel group comparison study.
Effect of supplement on accommodation of eye.
Japan |
Healthy adults
Adult |
Others
NO
Investigate the improvement of accommodation of eye in middle and old-aged adults who are perceiving eye fatigue after administration of supplement for 4 weeks.
Safety,Efficacy
Confirmatory
Accommodation of eye
0 week, 4 weeks
Subjective symptoms (questionnaire)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Ingestion of test food for 4 weeks
Ingestion of placebo for 4 weeks
45 | years-old | <= |
65 | years-old | > |
Male and Female
1. Age: 45 years or older, < 65 years old
2. Gender: Male or Female
3. Subjective eye fatigue
4. Have no eye diseases other than refractive error (near-sightedness, far-sightedness and astigmatism)
5. Cylinder eyesight (binocular vision) > 1.0. The specifications of eye-contact lens or glasses cannot be changed and replaced with new ones during the test period.
6. Written informed consent
1. Conduct of lasik surgery during the past 6 months
2. Presence or history of hepatitis diseases or severe renal, endocrine, cardiovascular, gastric, lung, hematologic and metabolic disorder diseases
3. Risk of onset of pollen allergy during the study period (July to November) excluding the case that the disease starts from current year
4. Current medications (excluding on-demand use)
5. Any medications (including eye drop) for indication of eye strain or health foods intake
6. Presence or history of drug/food allergy
7. Receipt of investigational product in other clinical studies during the past one month or currently participating in other clinical studies
8. Female who is pregnant, breast-feeding or intends to become pregnant
9. Patients whom principal investigator judges inappropriate to invite to this study
110
1st name | |
Middle name | |
Last name | Kei Yui |
Fancl Corporation
Research Institute, Health science research center
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
045-820-3755
ke-yui@fancl.co.jp
1st name | |
Middle name | |
Last name | Naomi Yuzawa |
IMEQRD co.Ltd
Sales Department
2-14-6 Nishi-Waseda,Shinjuku,Tokyo,Japan
03-6205-6222
n-yuzawa@imeqrd.co.jp
imeQ co.Ltd
FANCL Corporation
Profit organization
NO
2018 | Year | 07 | Month | 19 | Day |
Unpublished
Completed
2018 | Year | 06 | Month | 26 | Day |
2018 | Year | 07 | Month | 18 | Day |
2018 | Year | 07 | Month | 19 | Day |
2018 | Year | 10 | Month | 31 | Day |
2018 | Year | 11 | Month | 30 | Day |
2018 | Year | 12 | Month | 31 | Day |
2018 | Year | 07 | Month | 19 | Day |
2019 | Year | 08 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038141
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Research case data | |
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