Unique ID issued by UMIN | UMIN000019374 |
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Receipt number | R000022400 |
Scientific Title | The human clinical trial about improvement effect of MaquiBright supplementation on dry eye and eye fatigue symptoms |
Date of disclosure of the study information | 2015/10/16 |
Last modified on | 2016/10/17 10:18:20 |
The human clinical trial about improvement effect of MaquiBright supplementation on dry eye and eye fatigue symptoms
The human clinical trial about improvement effect of MaquiBright supplementation on dry eye and eye fatigue symptoms
The human clinical trial about improvement effect of MaquiBright supplementation on dry eye and eye fatigue symptoms
The human clinical trial about improvement effect of MaquiBright supplementation on dry eye and eye fatigue symptoms
Japan |
healthy subject
Ophthalmology |
Others
NO
To examine the efficacy and safety of 8-week oral intake of MaquiBright at 60 and 120 mg on dry eye and eye fatigue
Safety,Efficacy
tear film break-up time (BUT examination), strip meniscometry, Schirmer 1 test, subjective symptoms questionnaire (DEQS, VAS);investigation at start, 4 weeks treatment and after 8 weeks treatment
corneal and conjunctival epithelial disorder score, meibomian glands (MG) evaluation, continuous near-point measurement and flicker vision, visual acuity
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
3
Treatment
Food |
Test sample 1 (60mg/day): capsules containing MaquiBright 60mg and dextrin
Test sample 2 (120mg/day): capsules containing MaquiBright 120mg and dextrin
Placebo: capsules containing dextrin only
30 | years-old | <= |
60 | years-old | >= |
Male and Female
1) Healthy subjects, male and female aged from 30 to 60 years old (the ages are judged on the day signed the declaration of Consent)
2) Oneself feeling to have the three symptoms (dry eye, eye fatigue, and dull feeling)
3) Naked eye or wearing glasses
1.Subjects diagnosed with definite dry eye by Diagnosis Criteria of Dry Eye
2.Subjects wearing contact lenses.
3.Subjects consuming dietary supplement(s) or over the counter drug(s) included eye drops within participation one month.
4.Subjects are likely to change the number of times using artificial tears a day.
5.Subjects using artificial tears more than seven times a day.
6.Subjects who are using dry eye treatment drugs (However,it is selectable that the subjects have passed two weeks after discontinuation using a dry eye treatment drug, and do not use the drug during this study.)
7.Subjects who are currently suffering any ophthalmic disease (including conjunctival laxity),or anamnesis with serious eye disease
8.Subjects who are using eye drops for other ophthalmic diseases
9.Subjects diagnosed with Sjogren's syndrome
10.Subjects at risk of developing hay fever during October to january
11.Subjects with chronic disease of asthma
12.Subjects in medication, or who have anamnesis with serious eye disease that require medication
13.Subjects who underwent eye surgery during the past 3 months
14.Subjects who are allergic to the test sample
15.Subjects who had participated in other clinical trial within one month prior to the participation agreement of this study,or who are planning to participate in other clinical trials after the participation agreement of this study
16.Subjects who are planning pregnancy or breast-feeding during the study period
17.Others,subjects who are determined to be inappropriate as a subject by the doctor or researcher responsible for the trial
105
1st name | |
Middle name | |
Last name | Kazuo Tsubota |
Keio University School of Medicine
Ophthalmology
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
03-3353-1211
tsubota@z3.keio.jp
1st name | |
Middle name | |
Last name | Shintaro Yamada |
Tsubota-lab
Director
8F Aoyama KK, 2-26-35, Minamiaoyama, Minato-ku, Tokyo, Japan
03-6804-5888
inquiry_@_tsubota-lab.com
Tsubota-lab
Oryza Oil and Fat Chemical Co., Ltd
Profit organization
NO
2015 | Year | 10 | Month | 16 | Day |
Unpublished
Completed
2015 | Year | 10 | Month | 09 | Day |
2015 | Year | 10 | Month | 16 | Day |
2015 | Year | 10 | Month | 16 | Day |
2016 | Year | 10 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022400
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