UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024412
Receipt number R000028093
Scientific Title Safety and efficacy of eye care supplement intake
Date of disclosure of the study information 2016/10/14
Last modified on 2017/05/16 12:34:37

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Basic information

Public title

Safety and efficacy of eye care supplement intake

Acronym

The effect of supplement on eye functions.

Scientific Title

Safety and efficacy of eye care supplement intake

Scientific Title:Acronym

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

1st name
Middle name
Last name Takashi Koikeda

Organization

Shiba Palace Clinic

Division name

Chair

Zip code


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

1st name
Middle name
Last name Ko MASUDA

Organization

SOUKEN Co., Ltd

Division name

Management Division

Zip code


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 or person

Institute

Shiba Palace Clinic

Institute

Department

Personal name



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)



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

2016 Year 10 Month 14 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

2016 Year 09 Month 15 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028093


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name