UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017117 |
|---|---|
| Receipt number | R000019859 |
| Scientific Title | Multicenter study of Matrix Metalloproteinase (MMP)-9 expression on meibomian gland dysfunction using dry eye diagnostic device "InflammaDry" |
| Date of disclosure of the study information | 2015/04/15 |
| Last modified on | 2017/05/01 16:35:06 |
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Basic information
Public title
Multicenter study of Matrix Metalloproteinase (MMP)-9 expression on meibomian gland dysfunction using dry eye diagnostic device "InflammaDry"
Acronym
MMP-9 expression on meibomian gland dysfunction using dry eye diagnostic device InflammaDry
Scientific Title
Multicenter study of Matrix Metalloproteinase (MMP)-9 expression on meibomian gland dysfunction using dry eye diagnostic device "InflammaDry"
Scientific Title:Acronym
MMP-9 expression on meibomian gland dysfunction using dry eye diagnostic device InflammaDry
Region
| Japan |
Condition
Condition
Meibomian gland dysfunction
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate MMP-9 expression on meibomian gland dysfunction(MGD) using InflammaDry, and to investigate the association between MMP-9 expressions and MGD findings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
MMP-9 positive expression on InflammaDry in patients with meibomian gland dysfunction
Key secondary outcomes
Slit-lamp findings, meibo-score, Schirmer test, tear break-up time
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Gently dab the sampling fleece in multiple locations along the lower palpebral conjunctiva. Place the sampling fleece of the sample collector into test cassette and open the buffer vial and immerse the absorbent tip. Remove the absorbent tip from the buffer vial, replace the protective cap, and lay the test flat.
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
Patients who are diagnosed as MGD
Outpatients
Key exclusion criteria
Patients who may have the possibility of contagious diseases
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tohru Sakimoto |
Organization
Nihon University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
30-1 Ooyaguchikamimachi, Itabashi-ku
TEL
03-3972-8111(2531)
torusaki@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tohru Sakimoto |
Organization
Nihon University School of Medicine
Division name
Ophthalmology
Zip code
Address
30-1 Ooyaguchikamimachi, Itabashi-ku
TEL
03-3972-8111(2531)
Homepage URL
torusaki@gmail.com
Sponsor or person
Institute
Lid and Meibomian Gland Working Group
Institute
Department
Personal name
Funding Source
Organization
Lid and Meibomian Gland Working Group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
日本大学医学部附属板橋病院(東京都)、慶應義塾大学病院（東京都）、伊藤医院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 15 | 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
| 2015 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 13 | Day |
Last modified on
| 2017 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019859
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
