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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028538
Receipt No. R000032664
Scientific Title Examination on an influence of a test food product on oxidative stress in glaucoma patients
Date of disclosure of the study information 2017/08/07
Last modified on 2018/03/01

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Basic information
Public title Examination on an influence of a test food product on oxidative stress in glaucoma patients
Acronym Examination on an influence of a test food product on oxidative stress in glaucoma patients
Scientific Title Examination on an influence of a test food product on oxidative stress in glaucoma patients
Scientific Title:Acronym Examination on an influence of a test food product on oxidative stress in glaucoma patients
Region
Japan

Condition
Condition Normal tension glaucoma patients
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine an influence of a test food product on oxidative stress in normal tension glaucoma patients aged 40 and over and assigning them to take the test food product for four weeks.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 8-OHdG
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Four-week intake of the test food product
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Males and females with Japanese nationality aged 40 and over
2) Diagnosed with normal tension glaucoma
3) Persons who can bring their glaucoma medication on study days
4) Low in biological antioxidant potential (BAP) and high in oxidative stress (8-OHdG) in urine
Key exclusion criteria "1) Presence of severe ophthalmic disorder and regular visit to an ophthalmic clinic
2) High myopia
3) Within three months after eye surgery
4) Previous history of the LASIK procedure
5) Presence of disorder with a possible influence on study results (cancer, high-blood pressure, diabetes, amblyopia, autoimmune disorder, dysthyroidism, etc.)
6) Intake of a food product (antioxidant supplements other than vitamin C, etc.) with a possible influence on the study results at a frequency of once a week or more within the last month, or desired to take the food product at the frequency of once a week or more
7) Previous history of drug allergy or food allergy, possible onset of allergy by the study
8) Currently in treatment with medication that regulates blood pressure or blood flow
9) Presence of disorder that requires constant medication, or previous history of severe disorder that required treatment with medication
10) Regular intake of another supplement or non-prescription drug (including ophthalmic drops for purposes other than glaucoma treatment of glaucoma)
11) Persons whose results of clinical and physical examination prior to intake of the test food product significantly deviate from reference ranges
12) Current participation in another clinical study or participation in another clinical study within the last month since acquisition of the consent
13) Pregnant or desired to become pregnant and nurse during the study period
14) Determined to be unsuitable as subjects from results of the lifestyle survey
15) Determined by the investigator to be unsuitable for enrollment in this study
"
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name ochitani daisuke
Organization HUMA R&D CORP

Division name Clinical Development Division
Zip code
Address OekkusuBldg.10F,5-31-19 ShibaMinato-ku, Tokyo 108-0014 Japan
TEL 03-3431-1260
Email ochitani@huma-c.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name ochitani daisuke
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code
Address OekkusuBldg.10F,5-31-19 ShibaMinato-ku, Tokyo 108-0014 Japan
TEL 03-3431-1260
Homepage URL
Email ochitani@huma-c.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

Funding Source
Organization Wakomoto 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
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 07 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
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
2017 Year 07 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 02 Day
Last follow-up date
2017 Year 10 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 04 Day
Last modified on
2018 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032664

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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