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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017117
Receipt No. 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

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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
Last 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)
Email torusaki@gmail.com

Public contact
1st 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
Email torusaki@gmail.com

Sponsor
Institute Lid and Meibomian Gland Working Group
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019859

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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