UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized double-blind, placebo-controlled, cross-over trial for improving eye fatigue of healthy adult VDT workers.
Title of the study (Brief title)	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	Kazuo YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
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	Naoko SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://doi.org/10.1625/jcam.14.9
Results
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