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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024412
Receipt No. R000028093
Scientific Title Safety and efficacy of eye care supplement intake
Date of disclosure of the study information 2016/10/14
Last modified on 2017/05/16

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Basic information
Public title Safety and efficacy of eye care supplement intake
Acronym The effect of supplement on eye functions.
Scientific Title Safety and efficacy of eye care supplement intake
Scientific Title:Acronym The effect of supplement on eye functions.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effect of supplement on eye functions.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ocular accommodation function test on pre and post of the study.
Key secondary outcomes Kinetic vision test
Continuous accommodation near point test
3m visual acuity test
Schirmer test
Tear film breakup time(BUT) test

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 Maneuver
Interventions/Control_1 Intake of supplement containing Bilberry extract powder, 2 capsules per day, 6weeks
Interventions/Control_2 Intake of supplement without Bilberry extract powder, 2 capsules per day, 6weeks
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
45 years-old >=
Gender Male and Female
Key inclusion criteria 1) Japanese male and female aged 20 to 45 (at first observation including screening)
2) A person with symptoms of eyestrain on a daily basis
3) A person who is engaged in VDT work (PC or detailed work) on a daily basis (6H/day or more on average)
4) A person with symptoms of dry eye
Key exclusion criteria 1) A person who was not diagnosed with organic eye disease in clinical observations
2) A person who is not so extremely difficult to adjust eyesight with autorefractometer
3) A person who can adjust eyesight as 20/15(1.5) vision (both eyes)
4) A person who is relatively little tear secretion on Schirmer test
5) A person who is relatively short on tear breakup time
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Koikeda
Organization Shiba Palace Clinic
Division name Chair
Zip code
Address 6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL 03-5408-1590
Email jimukyoku@mail.souken-r.com

Public contact
Name of contact person
1st name
Middle name
Last name Ko MASUDA
Organization SOUKEN Co., Ltd
Division name Management Division
Zip code
Address 3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105
TEL 03-5408-1555
Homepage URL
Email k_masuda@mail.souken-r.com

Sponsor
Institute Shiba Palace Clinic
Institute
Department

Funding Source
Organization BGG Japan 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
2016 Year 10 Month 14 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 09 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 24 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
2016 Year 10 Month 14 Day
Last modified on
2017 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028093

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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