UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	effect of lid hygiene on meibomian gland dysfunction
Title of the study (Brief title)	effect of lid hygiene on meibomian gland dysfunction
Region	Japan

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

Objectives
Narrative objectives1	To investigate the treatment efficacy and safety of lid hygiene on meibomian gland dysfunction
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	subjective symptom, tear breakup time, fluorescein staining score, meibum, lid margin findings
Key secondary outcomes	DR1, functional visual acuity, confocal microscopy

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Behavior,custom Other
Interventions/Control_1	lid hygiene using eye shampoo
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	meibomian gland dysfunction
Key exclusion criteria	patient with severe ocular surface disease patient who had ocular surgery within 1 month
Target sample size	40

Research contact person
Name of lead principal investigator	Motoko Kawashima
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	81333531211
Email	motoko326@gmail.com

Public contact
Name of contact person	Motoko Kawashima
Organization	Keio University School of Medicine
Division name	Ophthalmology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	81333531211(63954)
Homepage URL
Email	motoko326@gmail.com

Sponsor
Institute	Department of Ophthalmology, Keio University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	mediproduct
Organization
Division
Category of Funding Organization	Profit organization
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

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 05 Day
Anticipated trial start date	2014 Year 07 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2014 Year 07 Month 02 Day
Last modified on	2016 Year 04 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000016821