UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of eye care supplement intake
Title of the study (Brief title)	The effect of supplement on eye functions.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effect of supplement on eye functions.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Ocular accommodation function test on pre and post of the study.
Key secondary outcomes	Kinetic vision test Continuous accommodation near point test 3m visual acuity test Schirmer test Tear film breakup time(BUT) 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 Maneuver
Interventions/Control_1	Intake of supplement containing Bilberry extract powder, 2 capsules per day, 6weeks
Interventions/Control_2	Intake of supplement without Bilberry extract powder, 2 capsules per day, 6weeks
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	45 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Japanese male and female aged 20 to 45 (at first observation including screening) 2) A person with symptoms of eyestrain on a daily basis 3) A person who is engaged in VDT work (PC or detailed work) on a daily basis (6H/day or more on average) 4) A person with symptoms of dry eye
Key exclusion criteria	1) A person who was not diagnosed with organic eye disease in clinical observations 2) A person who is not so extremely difficult to adjust eyesight with autorefractometer 3) A person who can adjust eyesight as 20/15(1.5) vision (both eyes) 4) A person who is relatively little tear secretion on Schirmer test 5) A person who is relatively short on tear breakup time
Target sample size	30

Research contact person
Name of lead principal investigator	Takashi Koikeda
Organization	Shiba Palace Clinic
Division name	Chair
Address	6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL	03-5408-1590
Email	jimukyoku@mail.souken-r.com

Public contact
Name of contact person	Ko MASUDA
Organization	SOUKEN Co., Ltd
Division name	Management Division
Address	3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105
TEL	03-5408-1555
Homepage URL
Email	k_masuda@mail.souken-r.com

Sponsor
Institute	Shiba Palace Clinic
Institute
Department

Funding Source
Organization	BGG Japan Corporation
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	2016 Year 10 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 15 Day
Anticipated trial start date	2016 Year 10 Month 24 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	2016 Year 10 Month 14 Day
Last modified on	2017 Year 05 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028093