UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024039 |
|---|---|
| Receipt number | 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 09:14:16 |
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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
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
ritoh@za2.so-net.ne.jp
Sponsor or person
Institute
Itoh Clinic
Department of Ophthalmology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027685
