UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of a Food Containing Extract of Ericaceae Fruits / Conifer for Reduction of Intraocular Pressure
Title of the study (Brief title)	Effects of a Food Containing Extract of Ericaceae Fruits / Conifer for Reduction of Intraocular Pressure
Region	Japan

Condition
Condition	N/A (healthy adults)
Classification by specialty	Ophthalmology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examines effects of a test food for reduction of intraocular pressure.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Value and rate changes of intraocular pressure (Screening vs Week 12)
Key secondary outcomes	*Secondary outcomes Value and rate changes of intraocular pressure (Screening vs Week 4; Screening vs Week 8) *Safety [1]Doctor's questions [2]Blood pressure, pulsation [3]Weight, body fat percentage, BMI [4]Blood test (adiponectin) [5]Blood biochemical test [6]Urine analysis *Other outcomes Subject's diary(From the first day of ingestion of a test material to the last day of the test)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Oral intake of the test food (1 pill in a day; 12 weeks)
Interventions/Control_2	Oral intake of the placebo food (1 pill in a day; 12 weeks)
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	[1]Males and Females aged 20-74 years [2]Individuals whose intraocular pressure is over 20mmHg at Week 0 [3]Individuals whose written informed consent has been obtained [4]Individuals who can have an examination in a designated day [5]Individuals judged appropriate for the study by the principal
Key exclusion criteria	[1]Individuals having glaucomatous optic disc disorder. [2]Individuals with serious disease. [3]Individuals with eye disease which has influence to intraocular pressure and measurement of ocular tension (ex. inflammatory disease, corneal disease). [4]Individuals who used a drug having influence to intraocular pressure in the past 4 weeks. [5]Individuals who have to wear contact lens from bedtime of the day before to the completion of the inspection at each visit.
Target sample size	40

Research contact person
Name of lead principal investigator	Masahiko Takeshi
Organization	Medical Corporation Shinanokai, Shinanozaka Clinic
Division name	Director
Address	3F Yotsuya Medhical Building, 20 Samoncho Shinjuku Tokyo 160-0017, JAPAN
TEL	03-5366-3006
Email	hi-nezu@trcp.co.jp

Public contact
Name of contact person	Ryoma Shimizu
Organization	TES Holdings Co., Ltd
Division name	Administrative Department of Clinical Trials
Address	6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL	03-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd
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)

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 01 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 05 Day
Anticipated trial start date	2017 Year 01 Month 12 Day
Last follow-up date
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 01 Month 05 Day
Last modified on	2017 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029141