UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025565 |
|---|---|
| Receipt number | R000029421 |
| Scientific Title | A verification study for improvement in eye dryness: A randomized double-blind placebo-controlled trial |
| Date of disclosure of the study information | 2017/07/22 |
| Last modified on | 2017/10/10 07:42:57 |
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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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029421
