UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023924
Receipt number 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 2022/09/08 23:02:03

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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 Shigeru
Middle name
Last name Kinoshita

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Frontier Medical Science and Technology for Ophthalmology

Zip code

6020841

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 Tomo
Middle name
Last name Suzuki

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Ophthalmology

Zip code

6020841

Address

465 Kajiicho Kamigyo-ku, Kyoto, Japan

TEL

(075)251-5578

Homepage URL


Email

tomosuzu@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



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

Ethics Committee of Kyoto Prefectural University of Medicine

Address

465 Kajiicho Kamigyo-ku, Kyoto, Japan

Tel

(075)251-5337

Email

rinri@koto.kpu-m.ac.jp


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

2012 Year 11 Month 01 Day

Anticipated trial start date

2012 Year 11 Month 01 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry

2023 Year 03 Month 31 Day

Date trial data considered complete

2023 Year 03 Month 31 Day

Date analysis concluded

2024 Year 03 Month 31 Day


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

2022 Year 09 Month 08 Day



Link to view the page

Value
https://center6.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