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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019374
Receipt No. 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

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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
Institute Tsubota-lab
Institute
Department

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
URL(English) https://upload.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


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