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 | 2024/09/09 14:58:21 |
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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, lipid composition of meibum
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy volunteer
and
patients with 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
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
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
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
京都市立病院、京都府立医科大学
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
| 2024 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027549
