UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination on an influence of a test food product on oxidative stress in glaucoma patients
Title of the study (Brief title)	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	ochitani daisuke
Organization	HUMA R&D CORP
Division name	Clinical Development Division
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	ochitani daisuke
Organization	HUMA R&D CORP
Division name	Clinical Development Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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