UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014590 |
|---|---|
| Receipt number | 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 18:32:21 |
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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
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
kazu@orthomedico.jp
Public contact
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
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016975
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