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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019150
Receipt No. R000022143
Scientific Title A randomized double-blind, placebo-controlled, cross-over trial for improving eye fatigue of healthy adult VDT workers.
Date of disclosure of the study information 2016/06/01
Last modified on 2017/04/10

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Basic information
Public title A randomized double-blind, placebo-controlled, cross-over trial for improving eye fatigue of healthy adult VDT workers.
Acronym A trial for improving eye fatigue of healthy adult VDT workers.
Scientific Title A randomized double-blind, placebo-controlled, cross-over trial for improving eye fatigue of healthy adult VDT workers.
Scientific Title:Acronym A trial for improving eye fatigue of healthy adult VDT workers.
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 crocetin on eye fatigue.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Accommodative function (Percentage of pupil constriction) (0, 4 week)
Key secondary outcomes Questionnaires (VAS)
Schirmer's test
Tear film break-up time
(0, 4 week)

Base
Study type Interventional

Study design
Basic design Cross-over
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
Interventions/Control_1 Duration: 4 weeks
Test material: Soft capsule contained 7.5 mg of crocetin
One capsule per day
Interventions/Control_2 Duration: 4 weeks
Test material: placebo soft capsule
One capsule per day
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
40 years-old >=
Gender Male and Female
Key inclusion criteria a) Healthy adults with a subjective symptom of eye fatigue.
b) Males and females aged 20 to 40 years old.
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 and/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/or 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 or herbal medicines.
j) Persons who take dietary supplements.
k) Persons who are allergic to medicines or foods related to the test material of this trial.
l) Pregnant women, lactating women, or women who plan to get pregnant during the trial period.
m) Persons who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial.
n) Smokers
o) Persons judged not suitable to participate in this trial by physician.
Target sample size 22

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 3F Sophia Ochanomizu, 2-4-3 Yushima, Bunkyo-ku, Tokyo
TEL 03-3818-0610
Email 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 3F Sophia Ochanomizu, 2-4-3 Yushima, Bunkyo-ku, Tokyo
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization RIKEN VITAMIN CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Seisin-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

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://doi.org/10.1625/jcam.14.9
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 09 Month 28 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 29 Day
Last follow-up date
2016 Year 02 Month 16 Day
Date of closure to data entry
2016 Year 02 Month 27 Day
Date trial data considered complete
2016 Year 03 Month 18 Day
Date analysis concluded
2016 Year 04 Month 18 Day

Other
Other related information

Management information
Registered date
2015 Year 09 Month 29 Day
Last modified on
2017 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022143

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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