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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025159
Receipt No. R000028100
Scientific Title Efficacy of expression treatment on o-MGD(obstructive meibomian gland dysfunction)
Date of disclosure of the study information 2017/02/01
Last modified on 2017/09/08

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Basic information
Public title Efficacy of expression treatment on o-MGD(obstructive meibomian gland dysfunction)
Acronym Efficacy of expression treatment
Scientific Title Efficacy of expression treatment on o-MGD(obstructive meibomian gland dysfunction)
Scientific Title:Acronym Efficacy of expression treatment
Region
Japan

Condition
Condition obstructive meibomian gland dysfunction
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to elucidate the effectiveness of expression treatment on o-MGD
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Tear break up time (one month after the treatment)
Key secondary outcomes Corneal and conjunctival staining score, DR-1 grade, Meibum expressibility with Shimazaki classification, Meibography

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Non-expressive treatments for one month(thermal therapy, lid hygiene, levofloxacin ophthalmic suspension 1.5% eyedrop qid, Fluorometholone ophthalmic suspension 0.1% tid, hyaluronic acid sodium ophthalmic suspension 0.1% qid, minocycline 200 mg po)
Interventions/Control_2 One month non-expressive treatment and single manual expression
Interventions/Control_3 One month non-expressive treatment and single mechanical expression
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients over 20 years old meeting the Japanese diagnostic definitions of MGD in 2010 who showed the obstruction of the meibomian glands and signd the informed consent
Key exclusion criteria Patients who have undergone LASIK or cataract surgery within one year, wear contact lens, have systemic diseases related to dry eyes, use specific medication which may induce dry eye or MGD, have eye disease other than MGD, is pregnant or lactating
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naohiko Nakayama
Organization Tokyo Dental College Ichikawa General Hospital
Division name Department of Ophthalmology
Zip code
Address 5-11-13, Sugano, Ichikawa, Chiba
TEL 047-322-0151
Email nnakayama@tdc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naohiko Nakayama
Organization Tokyo Dental College Ichikawa General Hospital
Division name Department of Ophthalmology
Zip code
Address 5-11-13, Sugano, Ichikawa, Chiba
TEL 047-322-0151
Homepage URL
Email nnakayama@tdc.ac.jp

Sponsor
Institute Tokyo Dental College Ichikawa General Hospital
Institute
Department

Funding Source
Organization Tokyo Dental College Ichikawa General Hospital
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 東京歯科大学市川総合病院(千葉県)

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 01 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
2016 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 12 Month 06 Day
Last modified on
2017 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028100

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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