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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014590
Receipt No. R000016975
Scientific Title A trial for improving oxidative stress in tear fluid A randomized double-blind placebo-controlled parallel-group study
Date of disclosure of the study information 2014/07/18
Last modified on 2017/01/30

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Basic information
Public title A trial for improving oxidative stress in tear fluid
A randomized double-blind placebo-controlled parallel-group study
Acronym A trial for improving oxidative stress in tear fluid
Scientific Title A trial for improving oxidative stress in tear fluid
A randomized double-blind placebo-controlled parallel-group study
Scientific Title:Acronym A trial for improving oxidative stress in tear fluid
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of "lutein" on oxidative stress in tear fluid
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Degree of oxidative stress
Pigment amount of macula lutea
Dry eye evaluation
Key secondary outcomes Questionnaires
Likert scale

Safety test
Physical examination
Urine analysis
Blood chemical analysis
Visual acuity 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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Duration: 8 weeks
Test material: lutein
One capsule two times per day before breakfast and dinner
Interventions/Control_2 Duration: 8 weeks
Test material: placebo
One capsule two times per day before breakfast and dinner
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
30 years-old <=
Age-upper limit
49 years-old >=
Gender Male and Female
Key inclusion criteria a) Persons who are between 30 and 49 years old

b) Persons who are aware of dry eyes

c) Persons who routinely use a TV game and PC or act the VDT more than 4 hour per day

d) Persons who routinely don`t use a glass or screen of blocking blue-light

e) Persons whose corrected visual acuity in both eyes is more than 1.0 and who don`t use contact lenses
Key exclusion criteria a)Persons who have previous medical history of malignant tumor or heart failure or myocardial infarction

b)Patients being treated for at least one of following diseases atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder,cerebrovascular disorder, rheumatism,diabetes mellitus, dyslipidemia,hypertension and other chronic disease

c)Persons who have ophthalmopathy or entropion or trichiasis

d)Persons who have ametropia and don`t be treated orthoptics properly

e)Persons who are strong astigmatism

f)Persons who are achromatopsia

g)Persons who were treated with LASIK

h)Persons who have cause of eyestrain except for neurological deficit,et al. or regulatory function

i)Persons who take medicines, herbal medicines

j)Persons who are allergic to medicines, or products related to the test material of this trial

k)Pregnant women, lactating women, or women who want to get pregnant during the trial period

l)Persons who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial

m)Persons who are judged not suitable to participate in this trial by physician
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kazuo YAMAMOTO
Organization ORTHOMEDICO, Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL 03-3818-0610
Email kazu@orthomedico.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Naoko SUZUKI
Organization ORTHOMEDICO, Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization BIO ACTIVES JAPAN Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Seishin-kai Medical Association Inc, Takara Medical Clinic.
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 医療法人社団 盛心会 タカラクリニック (東京都)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 18 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
2014 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 17 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
2014 Year 12 Month 31 Day
Date trial data considered complete
2014 Year 12 Month 31 Day
Date analysis concluded
2014 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 18 Day
Last modified on
2017 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016975

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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