UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	To investigate the effect of the eyemakeup on ocular surface in healthy volunteers
Title of the study (Brief title)	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	Reiko Arita
Organization	Itoh Clinic,
Division name	Ophthalmology
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	Reiko Arita
Organization	Itoh Clinic
Division name	Ophthalmology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000027685