UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018535
Receipt number 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 09:12:18

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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 or person

Institute

Itoh Clinic

Institute

Department

Personal name



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

Value
https://center6.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