UMIN-CTR Clinical Trial

Basic information
Public title	A verification study for improvement in eye dryness: A randomized double-blind placebo-controlled trial
Acronym	A verification study for improvement in eye dryness
Scientific Title	A verification study for improvement in eye dryness: A randomized double-blind placebo-controlled trial
Scientific Title:Acronym	A verification study for improvement in eye dryness
Region	Japan

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

Objectives
Narrative objectives1	To verify the improvement effects for eye dryness and eye fatigue through ingestion of the test food
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Schirmer's test (the average of right and left eyes)
Key secondary outcomes	1. Schirmer's test (dominant and nondominant eyes, right and left eyes) 2. BUT (tear film break-up time) test 3. Subjective symptoms VAS (Visual Analogue Scale) DEQS (Dry Eye related Quality of life Score 4. Percentage of pupillary response 5. Flicker test 6. Doctor's observation

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	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 4 weeks Test material: MaquiBright capsule Dose: 1 capsule for a day Administration: Take 1 capsule after breakfast *If you forget to take the capsule, take it during the same day
Interventions/Control_2	Duration: 4 weeks Test material: Placebo capsule Dose: 1 capsule for a day Administration: Take 1 capsule after breakfast *If you forget to take the capsule, take it during the same 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	30 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	1. Those with eyes dryness 2. Those who suffer from eye fatigue 3. Those who usually play TV games, use PCs and/or a smart phone, or those who work on Visual Display Terminals (VDT) operation for four (4) hours or more per day 4. Those who have corrected vision of both eyes with 1.0 or more and who do not use contact lenses, or, those who can switch to using eye glasses during the test period
Key exclusion criteria	1. At least one previous medical history of malignant tumors, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Those who were diagnosed dry eye syndrome 4. Those who changed the frequency of use artificial lachrymal fluid per day during the test period and use artificial lachrymal fluid seven times or more per day 5. Those who receive medication for dry eye syndrome (provided that a patient has not taken the medication for two (2) weeks and do not take medicines during the test period) 6. Those suffering from eye diseases (including conjunctivochalasis), and those who have previous medical history of eye diseases 7. Those who use eye drops for treatment of eye diseases 8. Those who are diagnosed with Sjogren's syndrome 9. Those who are susceptible to pollen allergy or are suffering from chronic asthma 10. Those who are receiving pharmacotherapy or who need pharmacotherapy 11. Those who suffer from meibomian gland dysfunction 12. Those who work late-night shift and the life-styles are irregular 13. Current use of medications (including herbal medicines) or/and supplements 14. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 15. Those who are allergic to medicines and/or the test food related products 16. Those who are pregnant, breast-feeding, or are expected to become pregnant during the test period 17. Those who had participated another clinical test for three months when you signed the informed consent form for this trial 18. Others considered as inappropriate for this test by the doctor responsible for the test
Target sample size	70

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
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	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	ORYZA OIL & FAT CHEMICAL CO., LTD. Anklam Extrakt GmbH Maqui New Life S.A.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Ario Nishiarai Eye 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	2017 Year 07 Month 22 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	2016 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date	2016 Year 11 Month 29 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	2017 Year 01 Month 06 Day
Last modified on	2017 Year 10 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029421

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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