UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter study of Matrix Metalloproteinase (MMP)-9 expression on meibomian gland dysfunction using dry eye diagnostic device "InflammaDry"
Title of the study (Brief title)	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	Tohru Sakimoto
Organization	Nihon University School of Medicine
Division name	Department of Ophthalmology
Address	30-1 Ooyaguchikamimachi, Itabashi-ku
TEL	03-3972-8111(2531)
Email	torusaki@gmail.com

Public contact
Name of contact person	Tohru Sakimoto
Organization	Nihon University School of Medicine
Division name	Ophthalmology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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