Unique ID issued by UMIN | UMIN000019150 |
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Receipt number | R000022143 |
Scientific Title | A randomized double-blind, placebo-controlled, cross-over trial for improving eye fatigue of healthy adult VDT workers. |
Date of disclosure of the study information | 2016/06/01 |
Last modified on | 2017/04/10 11:27:39 |
A randomized double-blind, placebo-controlled, cross-over trial for improving eye fatigue of healthy adult VDT workers.
A trial for improving eye fatigue of healthy adult VDT workers.
A randomized double-blind, placebo-controlled, cross-over trial for improving eye fatigue of healthy adult VDT workers.
A trial for improving eye fatigue of healthy adult VDT workers.
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To investigate the effect of crocetin on eye fatigue.
Safety,Efficacy
Confirmatory
Pragmatic
Accommodative function (Percentage of pupil constriction) (0, 4 week)
Questionnaires (VAS)
Schirmer's test
Tear film break-up time
(0, 4 week)
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Duration: 4 weeks
Test material: Soft capsule contained 7.5 mg of crocetin
One capsule per day
Duration: 4 weeks
Test material: placebo soft capsule
One capsule per day
20 | years-old | <= |
40 | years-old | >= |
Male and Female
a) Healthy adults with a subjective symptom of eye fatigue.
b) Males and females aged 20 to 40 years old.
c) Persons who routinely use a TV game and PC or act the VDT more than 4 hour per day.
d) Persons who routinely don`t use a glass or screen of blocking blue-light.
e) Persons whose corrected visual acuity in both eyes is more than 1.0 and who don`t use contact lenses.
a) Persons who have previous medical history of malignant tumor, or heart failure and/or myocardial infarction.
b) Patients being treated for at least one of following diseases: atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, and/or other chronic disease.
c) Persons who have ophthalmopathy or entropion or trichiasis.
d) Persons who have ametropia and don`t be treated orthoptics properly.
e) Persons who are strong astigmatism.
f) Persons who are achromatopsia.
g) Persons who were treated with LASIK.
h) Persons who have cause of eyestrain except for neurological deficit,et al. or regulatory function.
i) Persons who take medicines or herbal medicines.
j) Persons who take dietary supplements.
k) Persons who are allergic to medicines or foods related to the test material of this trial.
l) Pregnant women, lactating women, or women who plan to get pregnant during the trial period.
m) Persons who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial.
n) Smokers
o) Persons judged not suitable to participate in this trial by physician.
22
1st name | |
Middle name | |
Last name | Kazuo YAMAMOTO |
ORTHOMEDICO Inc.
R&D Department
3F Sophia Ochanomizu, 2-4-3 Yushima, Bunkyo-ku, Tokyo
03-3818-0610
kazu@orthomedico.jp
1st name | |
Middle name | |
Last name | Naoko SUZUKI |
ORTHOMEDICO Inc.
R&D Department
3F Sophia Ochanomizu, 2-4-3 Yushima, Bunkyo-ku, Tokyo
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
RIKEN VITAMIN CO., LTD.
Profit organization
Seisin-kai Medical Association Inc, Takara Medical Clinic.
NO
2016 | Year | 06 | Month | 01 | Day |
Published
http://doi.org/10.1625/jcam.14.9
Completed
2015 | Year | 09 | Month | 28 | Day |
2015 | Year | 09 | Month | 29 | Day |
2016 | Year | 02 | Month | 16 | Day |
2016 | Year | 02 | Month | 27 | Day |
2016 | Year | 03 | Month | 18 | Day |
2016 | Year | 04 | Month | 18 | Day |
2015 | Year | 09 | Month | 29 | Day |
2017 | Year | 04 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022143
Research Plan | |
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