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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033200
Receipt No. 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

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Basic information
Public title Effect of a test food on blood antioxidative action of primary open-angle glaucoma patients.
Acronym Effects of a test food on antioxidative action in blood.
Scientific Title Effect of a test food on blood antioxidative action of primary open-angle glaucoma patients.
Scientific Title:Acronym Effects of a test food on antioxidative action in blood.
Region
Japan

Condition
Condition Primary open-Angle Glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Antioxidative stress marker in blood, intraocular pressure
Key secondary outcomes Adverse Effects/Side Effects

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Oral intake of test food (1 pill in a day, 4 weeks)
Interventions/Control_2
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
20 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria [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
Key exclusion criteria [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.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Masaki
Middle name
Last name Tanito
Organization Shimane University
Division name Ophthalmology
Zip code 693-8501
Address 89-1, Shiochi-cho, Izumo, Shimane Prefecture
TEL 0853-20-2284
Email mtanito@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name Yasutaka
Middle name
Last name Takagi
Organization Santen Pharmaceutical Co., Ltd.
Division name Japan Medical Affairs Group
Zip code 530-8552
Address 4-20, Ofukacho, Kita-ku, Osaka 530-8552, Japan
TEL +81-6-4802-9337
Homepage URL
Email clinical@santen.co.jp

Sponsor
Institute Shimane University
Institute
Department

Funding Source
Organization Santen 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 Shimane University
Address 89-1, Shiochi-cho, Izumo, Shimane Prefecture
Tel 0853-20-2259
Email kenkyu@med.shimane-u.ac.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 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.)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 05 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 18
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
2018 Year 02 Month 26 Day
Date of IRB
2018 Year 03 Month 16 Day
Anticipated trial start date
2018 Year 07 Month 06 Day
Last follow-up date
2019 Year 01 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 29 Day
Last modified on
2019 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037855

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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