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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023924
Receipt No. R000027549
Scientific Title The study of meibomian gland and ocular surface physiology related to sex steroid hormones
Date of disclosure of the study information 2016/09/05
Last modified on 2016/09/03

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Basic information
Public title The study of meibomian gland and ocular surface physiology related to sex steroid hormones
Acronym The study of meibomian gland and ocular surface physiology related to sex steroid hormones
Scientific Title The study of meibomian gland and ocular surface physiology related to sex steroid hormones
Scientific Title:Acronym The study of meibomian gland and ocular surface physiology related to sex steroid hormones
Region
Japan

Condition
Condition meibomian gland diseases

Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the control of sex steroid hormones on the meibomian gland physiology
Basic objectives2 Others
Basic objectives -Others Evaluation of the relation between meibomian gland physiology and sex steroid hormones
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Diameter of meibomian gland orifice
Key secondary outcomes Volume of meibum, Morphology of meibomian gland, Break-up time of tear film

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria Healthy volunteer
and
meibomian gland diseases
Key exclusion criteria Eye and/or general diseases, medication, smoking, or wearing contact lens
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Kinoshita
Organization Kyoto Prefectural University of Medicine
Division name Department of Frontier Medical Science and Technology for Ophthalmology
Zip code
Address 465 Kajiicho Kamigyo-ku, Kyoto, Japan
TEL (075)251-5772
Email shigeruk@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomo Suzuki
Organization Kyoto Prefectural University of Medicine
Division name Department of Ophthalmology
Zip code
Address 465 Kajiicho Kamigyo-ku, Kyoto, Japan
TEL (075)251-5578
Homepage URL
Email tomosuzu@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Japanese Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
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 09 Month 05 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 Enrolling by invitation
Date of protocol fixation
2006 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Adding to the relation between meibomian glands and sex steroid hormones, commensal bacteria in meibomian glands is also examined.

Management information
Registered date
2016 Year 09 Month 03 Day
Last modified on
2016 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027549

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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