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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024039
Receipt No. R000027685
Scientific Title To investigate the effect of the eyemakeup on ocular surface in healthy volunteers
Date of disclosure of the study information 2016/09/13
Last modified on 2018/03/16

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Basic information
Public title To investigate the effect of the eyemakeup on ocular surface in healthy volunteers
Acronym To investigate the effect of the eyemakeup on ocular surface
Scientific Title To investigate the effect of the eyemakeup on ocular surface in healthy volunteers
Scientific Title:Acronym To investigate the effect of the eyemakeup on ocular surface
Region
Japan

Condition
Condition healthy volunteers
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the effect of the eyemakeup on ocular surface
Basic objectives2 Others
Basic objectives -Others The purpose of this study is to investigate the effect of the eyemakeup on ocular surface
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes tear lipid dynamics measured by DR-1a
Key secondary outcomes Ocular surface parameters(BUT, fluorescein staining score, schirmer test value, ocular symptoms)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Behavior,custom Other
Interventions/Control_1 heavy eyemakeup with insideline intervention
Interventions/Control_2 mild eyemakeup
Interventions/Control_3 control no makeup
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
65 years-old >=
Gender Female
Key inclusion criteria Female
Age more than 20 years old
Key exclusion criteria Those who have any ocular diseases
Those who have allergies for cosmetics
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Reiko Arita
Organization Itoh Clinic,
Division name Ophthalmology
Zip code
Address 626-11,Minaminakano, Minuma-Ku, Saitama City, Saitama, Japan
TEL 048-686-5588
Email ritoh@za2.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Reiko Arita
Organization Itoh Clinic
Division name Ophthalmology
Zip code
Address 626-11, Minaminakano, Minuma-Ku, Saitama,
TEL 048-686-5588
Homepage URL
Email ritoh@za2.so-net.ne.jp

Sponsor
Institute Itoh Clinic
Department of Ophthalmology
Institute
Department

Funding Source
Organization Lid and meibomian gland working group
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Haneki no mori 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 伊藤医院、羽木の森アイクリニック

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 13 Day

Related information
URL releasing protocol
Publication of results Partially published

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 05 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 13 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 09 Month 13 Day
Last modified on
2018 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027685

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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