UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of LED low-level phototherapy (LED-LLLT) for Meibomian gland dysfunction
Title of the study (Brief title)	Evaluation of LED low-level phototherapy (LED-LLLT) for Meibomian gland dysfunction
Region	Japan

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

Objectives
Narrative objectives1	Perform LED-LLLT using Lutronic HEALITE II. After that, we examined the effect of Meibomian gland dysfunction and the effects of around the eye tissues and ocular surface findings, as well as the effect of ocular surface and safety on treatment.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Phase I

Assessment
Primary outcomes	Meibum ( evalution of Lipid from meibomian gland), lid margin evaluation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	LED-Low Level Light Therapy
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	People who was diagnosed with meibomian gland dysfunction with subjective symptom of dry eye
Key exclusion criteria	people who cannot visit on designated date people who are under treatment of ocular disease or systemic disease People with a tattoo people who cannot take out contact lens and take makeup off on investigation days Pregnant, lactating woman people who are claustrophobia
Target sample size	10

Research contact person
Name of lead principal investigator	Motoko Kawashima
Organization	Haneginomori Eye Clinic
Division name	Ophthalmology
Address	4-26-4 daita, Setakaga-ku, Tokyo, Japan
TEL	03-6265-8777
Email	motoko326@gmail.com

Public contact
Name of contact person	Motoko Kawashima
Organization	Haneginomori Eye Clinic
Division name	Ophthalmology
Address	4-26-4 daita, Setakaga-ku, Tokyo, Japan
TEL	03-6265-8777
Homepage URL
Email	motoko326@gmail.com

Sponsor
Institute	Haneginomori Eye Clinic
Institute
Department

Funding Source
Organization	Haneginomori Eye Clinic
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

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 06 Day
Anticipated trial start date	2017 Year 03 Month 06 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	2018 Year 01 Month 22 Day
Last modified on	2018 Year 03 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035229