UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024043 |
|---|---|
| Receipt number | 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 09:16:08 |
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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
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
Ophthalmology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027688
