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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018535
Receipt No. R000021439
Scientific Title Evaluation of LipiFlow® treatment for meibomian gland dysfunction
Date of disclosure of the study information 2015/08/04
Last modified on 2017/02/03

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Basic information
Public title Evaluation of LipiFlow® treatment for meibomian gland dysfunction
Acronym Evaluation of LipiFlow® treatment
Scientific Title Evaluation of LipiFlow® treatment for meibomian gland dysfunction
Scientific Title:Acronym Evaluation of LipiFlow® treatment
Region
Japan

Condition
Condition Evaluation of LipiFlow® treatment for Meibomian Gland Dysfunction
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 LipiFlow® is a treatment for Meibomian gland diseases approved by FDA in Unites States. The purpose of this study is to evaluate the efficacy of LipiFlow® for Japanse MGD patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Lipid layer thickness
Key secondary outcomes symptoms, tear brak-up time, temperature of eye and sourounded tissue, tear volume, etc.

Base
Study type Interventional

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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 LipiFlow® treatment
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Subjects fulfilled teh criteria of obstructive MGD determined by Japan MGD working group
Key exclusion criteria MGD patient with any other ocular disease (except cataract)
subjects without wriiten informed consent
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Reiko Arita
Organization Itoh Clinic
Division name Department of Opthalmology
Zip code
Address 626-11 Minami-Nakano, Minuma, Saitama 337-0042
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 Department of Ophthalmology
Zip code
Address 626-11 Minami-Nakano, Minuma, Saitama 337-0042
TEL 048-686-5588
Homepage URL
Email ritoh@za2.so-net.ne.jp

Sponsor
Institute Itoh Clinic
Institute
Department

Funding Source
Organization none
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

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 04 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 Open public recruiting
Date of protocol fixation
2014 Year 12 Month 18 Day
Date of IRB
Anticipated trial start date
2014 Year 12 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 04 Day
Last modified on
2017 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021439

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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