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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024043
Receipt No. R000027688
Scientific Title Evaluation of morphology and function of meibomian glands in patients with benign prostatic hyperplasia
Date of disclosure of the study information 2016/09/13
Last modified on 2018/03/16

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Basic information
Public title Evaluation of morphology and function of meibomian glands in patients with benign prostatic hyperplasia
Acronym Evaluation of morphology and function of meibomian glands in patients with benign prostatic hyperplasia
Scientific Title Evaluation of morphology and function of meibomian glands in patients with benign prostatic hyperplasia
Scientific Title:Acronym Evaluation of morphology and function of meibomian glands in patients with benign prostatic hyperplasia
Region
Japan

Condition
Condition patients with benign prostatic hyperplasia
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the relationship between morphology and function of meibomian glands, tear film related parameters and alopecia
Basic objectives2 Others
Basic objectives -Others To investigate the relationship between morphology and function of meibomian glands, tear film related parameters and alopecia
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ocular symptoms, Alopecia grading, tear film breakup time, lid margin abnormalities, ocular surface staining, meiboscore, meibum grading, Schirmer value, systemic disease, tear interferometry,
Key secondary outcomes

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
Key inclusion criteria Patients with benign prostatic hyperplasia diagnosed in internal medicine or urology
Key exclusion criteria Subjects who have ocular diseases
Target sample size 100

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
Email 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
Email ritoh@za2.so-net.ne.jp

Sponsor
Institute Itoh Clinic
Ophthalmology
Institute
Department

Funding Source
Organization Itoh Clinic
Ophthalmology
Lid and meibomian gland working group
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 伊藤医院

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 13 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 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 Ocular symptoms, alopecia, lid margin abnormalities, ocular surface staining, tear film break up time, meiboscore, meibum grading, Schirmer value, tear interferometry, systematic disease

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/ctr_e/ctr_view.cgi?recptno=R000027688

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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