UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033098
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email h.shimada@ttc-tokyo.co.jp

Sponsor
Institute TTC Co., Ltd.
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037744

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.