UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033098 |
|---|---|
| Receipt number | R000037744 |
| Scientific Title | Effect of test supplement on eye strain: A randomized, double blinded, placebo controlled, and parallel group comparison study |
| Date of disclosure of the study information | 2018/06/22 |
| Last modified on | 2018/12/28 16:09:30 |
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Basic information
Public title
Effect of test supplement on eye strain: A randomized, double blinded, placebo controlled, and parallel group comparison study
Acronym
Effect of test supplement on eye strain
Scientific Title
Effect of test supplement on eye strain: A randomized, double blinded, placebo controlled, and parallel group comparison study
Scientific Title:Acronym
Effect of test supplement on eye strain
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to verify the effect of test supplement on eye strain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The scores of questionnaire on eye strain, in variation of before and after of VDT load
Key secondary outcomes
The scores of questionnaire on eye strain before VDT load, The scores of questionnaire on eye strain after VDT load, DEQS, Tear breakup time, Corneal Fluorescein Staining Pattern, Schirmer's test 1
Subgroup analysis using scores of questionnaire and other measurements
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
Ingestion of test supplement for 4 consecutive weeks
Interventions/Control_2
Ingestion of placebo for 4 consecutive weeks
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
| 45 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Subjects aged from 45 to 65 years old
(2) Subjects with eye strain by VDT load
Key exclusion criteria
(1)Subjects who have amblyopia or strabismus
(2) Subjects who have history of the organic eye disease (e.g., cataract, glaucoma, diabetic retinopathy, and age-related macular degeneration)
(3)Subjects who are under medication and/or medical treatment for eye disease (e.g., asthenopia and dry eye)
(4)Subjects who have history of the autoimmune disease (e.g., Sjogren syndrome, Basedow's disease, Hashimoto's disease, rheumatoid arthritis)
(5)Subjects who have a severe ametropia from result of screening test
(6)Subjects who use eye drops (including over-the-counter medicine) more than 4 days in a week (excluding artificial tears type eye drop (e.g., Soft santear, artificial tear Mytear eye drop)
(7)Subjects who routinely take food with health claim or health foods, quasi-drug, or medicine related to eye wellness / or take them a month before start of this study
(8)Subjects who have history or plan in study period to take punctual plug and punctual closing surgery
(9)Subjects who have history of ophthalmic surgery (including LASIK) within a year before start of study or have a schedule of ophthalmic surgery in study period
(10)Subjects who have suffering from any disease or who with a case history of a serious disease that needed medication
(11)Subjects who have possibilities for emerging allergy related to the study
(12)Subjects who can't carry out the VDT loading test during study period
(13)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(14)Subjects who have under treatment or a history of serious disease
(15)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on baseline examination
(16)Subjects who intend to become pregnant or lactating
(17)Subjects who have participated in other clinical study
(18)Subjects who are judged as unsuitable by doctor for other reasons
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Yui |
Organization
FANCL Corporation
Division name
Research Institute, Health science research center
Zip code
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3755
ke-yui@fancl.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Shimada |
Organization
TTC Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
Address
1-20-2, Ebisu-nishi, Shibuya-ku, Tokyo, Japan
TEL
03-5459-5329
Homepage URL
h.shimada@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2018 | Year | 06 | 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
| 2018 | Year | 06 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 23 | 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
| 2018 | Year | 06 | Month | 22 | Day |
Last modified on
| 2018 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037744
