UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of expression treatment on o-MGD(obstructive meibomian gland dysfunction)
Title of the study (Brief title)	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	Naohiko Nakayama
Organization	Tokyo Dental College Ichikawa General Hospital
Division name	Department of Ophthalmology
Address	5-11-13, Sugano, Ichikawa, Chiba
TEL	047-322-0151
Email	nnakayama@tdc.ac.jp

Public contact
Name of contact person	Naohiko Nakayama
Organization	Tokyo Dental College Ichikawa General Hospital
Division name	Department of Ophthalmology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 31 Day
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

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Publication of results	Unpublished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