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
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
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
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
