UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019374
Receipt number R000022400
Scientific Title The human clinical trial about improvement effect of MaquiBright supplementation on dry eye and eye fatigue symptoms
Date of disclosure of the study information 2015/10/16
Last modified on 2016/10/17 10:18:20

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Basic information

Public title

The human clinical trial about improvement effect of MaquiBright supplementation on dry eye and eye fatigue symptoms

Acronym

The human clinical trial about improvement effect of MaquiBright supplementation on dry eye and eye fatigue symptoms

Scientific Title

The human clinical trial about improvement effect of MaquiBright supplementation on dry eye and eye fatigue symptoms

Scientific Title:Acronym

The human clinical trial about improvement effect of MaquiBright supplementation on dry eye and eye fatigue symptoms

Region

Japan


Condition

Condition

healthy subject

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the efficacy and safety of 8-week oral intake of MaquiBright at 60 and 120 mg on dry eye and eye fatigue

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

tear film break-up time (BUT examination), strip meniscometry, Schirmer 1 test, subjective symptoms questionnaire (DEQS, VAS);investigation at start, 4 weeks treatment and after 8 weeks treatment

Key secondary outcomes

corneal and conjunctival epithelial disorder score, meibomian glands (MG) evaluation, continuous near-point measurement and flicker vision, visual acuity


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

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Test sample 1 (60mg/day): capsules containing MaquiBright 60mg and dextrin

Interventions/Control_2

Test sample 2 (120mg/day): capsules containing MaquiBright 120mg and dextrin

Interventions/Control_3

Placebo: capsules containing dextrin only

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

30 years-old <=

Age-upper limit

60 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Healthy subjects, male and female aged from 30 to 60 years old (the ages are judged on the day signed the declaration of Consent)
2) Oneself feeling to have the three symptoms (dry eye, eye fatigue, and dull feeling)
3) Naked eye or wearing glasses

Key exclusion criteria

1.Subjects diagnosed with definite dry eye by Diagnosis Criteria of Dry Eye
2.Subjects wearing contact lenses.
3.Subjects consuming dietary supplement(s) or over the counter drug(s) included eye drops within participation one month.
4.Subjects are likely to change the number of times using artificial tears a day.
5.Subjects using artificial tears more than seven times a day.
6.Subjects who are using dry eye treatment drugs (However,it is selectable that the subjects have passed two weeks after discontinuation using a dry eye treatment drug, and do not use the drug during this study.)
7.Subjects who are currently suffering any ophthalmic disease (including conjunctival laxity),or anamnesis with serious eye disease
8.Subjects who are using eye drops for other ophthalmic diseases
9.Subjects diagnosed with Sjogren's syndrome
10.Subjects at risk of developing hay fever during October to january
11.Subjects with chronic disease of asthma
12.Subjects in medication, or who have anamnesis with serious eye disease that require medication
13.Subjects who underwent eye surgery during the past 3 months
14.Subjects who are allergic to the test sample
15.Subjects who had participated in other clinical trial within one month prior to the participation agreement of this study,or who are planning to participate in other clinical trials after the participation agreement of this study
16.Subjects who are planning pregnancy or breast-feeding during the study period
17.Others,subjects who are determined to be inappropriate as a subject by the doctor or researcher responsible for the trial

Target sample size

105


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo Tsubota

Organization

Keio University School of Medicine

Division name

Ophthalmology

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-3353-1211

Email

tsubota@z3.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shintaro Yamada

Organization

Tsubota-lab

Division name

Director

Zip code


Address

8F Aoyama KK, 2-26-35, Minamiaoyama, Minato-ku, Tokyo, Japan

TEL

03-6804-5888

Homepage URL


Email

inquiry_@_tsubota-lab.com


Sponsor or person

Institute

Tsubota-lab

Institute

Department

Personal name



Funding Source

Organization

Oryza Oil and Fat Chemical 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

2015 Year 10 Month 16 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

2015 Year 10 Month 09 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 16 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

2015 Year 10 Month 16 Day

Last modified on

2016 Year 10 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022400


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name