Unique ID issued by UMIN | UMIN000033200 |
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Receipt number | R000037855 |
Scientific Title | Effect of a test food on blood antioxidative action of primary open-angle glaucoma patients. |
Date of disclosure of the study information | 2018/10/05 |
Last modified on | 2019/07/04 13:54:00 |
Effect of a test food on blood antioxidative action of primary open-angle glaucoma patients.
Effects of a test food on antioxidative action in blood.
Effect of a test food on blood antioxidative action of primary open-angle glaucoma patients.
Effects of a test food on antioxidative action in blood.
Japan |
Primary open-Angle Glaucoma
Ophthalmology |
Others
NO
To investigate the effect of a test food on blood antioxidative action of primary open-angle glaucoma patients. And effect on intraocular pressure are also investigated.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Antioxidative stress marker in blood, intraocular pressure
Adverse Effects/Side Effects
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
1
Prevention
Food |
Oral intake of test food (1 pill in a day, 4 weeks)
20 | years-old | <= |
70 | years-old | > |
Male and Female
[1]Males and Females aged 20 years over and aged under 70 years old
[2] Individuals whose written informed consent has been obtained
[3]Individuals whose both eye were prevent from glaucoma progression by treating with 1 to 3 medication, and individuals who do not need the ophthalmic surgery including glaucoma operation
[4] Individuals who want to take the test food
[5] Individuals whose intraocular pressure was higher than 15 mmHg with Goldmann applanation tonometer in at least one eye.
[6] Individuals who can measure the intraocular pressure with ICare HOME tonoometer
[7] Individuals whose measuring times of intraocular pressure with ICare HOME tonometer in pre-dosing period were greater than (days of pre-dosing period x2) times
[1] Individuals with serious systematic disease
[2] individuals with ocular disease which may leads the blindness except glaucoma or mild cataract
[3] Individuals with hepatic or renal failure, cardiac failure, renal failure which having influence to supplement evaluation.
[4] individuals with cigarettes smoker
[5] Individuals who continuously used a antioxidative supplement or have plan to use said supplements during the study period
[6] Individuals who are likely to change the lifestyle (long journey, change in Eating habits etc.).
[7] Individuals who is pregnant, lactating, or may possibly be pregnant.
[8] Individuals who entry into another clinical trial, or has a history of the entry into other clinical trials within 3 months
[9] Individuals with allergy to test food or who may possibly be allergy to test food.
[10] Individuals who are inappropriate case judged by investigator or subinvestigators.
20
1st name | Masaki |
Middle name | |
Last name | Tanito |
Shimane University
Ophthalmology
693-8501
89-1, Shiochi-cho, Izumo, Shimane Prefecture
0853-20-2284
mtanito@med.shimane-u.ac.jp
1st name | Yasutaka |
Middle name | |
Last name | Takagi |
Santen Pharmaceutical Co., Ltd.
Japan Medical Affairs Group
530-8552
4-20, Ofukacho, Kita-ku, Osaka 530-8552, Japan
+81-6-4802-9337
clinical@santen.co.jp
Shimane University
Santen Pharmaceutical Co., Ltd.
Profit organization
Shimane University
89-1, Shiochi-cho, Izumo, Shimane Prefecture
0853-20-2259
kenkyu@med.shimane-u.ac.jp
NO
松江赤十字病院(島根県)/Matsue Red Cross Hospital (Shimane Pref.)
島根大学(島根県)/ Shimane University (Shimane pref.)
2018 | Year | 10 | Month | 05 | Day |
Unpublished
18
Completed
2018 | Year | 02 | Month | 26 | Day |
2018 | Year | 03 | Month | 16 | Day |
2018 | Year | 07 | Month | 06 | Day |
2019 | Year | 01 | Month | 25 | Day |
2018 | Year | 06 | Month | 29 | Day |
2019 | Year | 07 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037855
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