UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect on the Tear Film Lipid Layer after Liposomal Spray in the Dry Eyes with Meibomian Gland Dysfunction
Title of the study (Brief title)	Liposomal Spray and Tear Film Lpid Layer
Region	Japan

Condition
Condition	Dry eyes with meibomian gland dysfuncion
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of liposlmal spray applicaion on the tear film lipid layer in dry eyes with meibomian gland dysfucntion (MGD).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time course of lipid layer thickness after liposomal spray application
Key secondary outcomes	Tear interferometric pattern Non invasive tear film breakup time Tear meniscus height Blink rate Subjective Symptoms

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Single application of liposomal spray
Interventions/Control_2	Single application of normal saline
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients diagnosed as dry eye by 2006 diagnostic criteria Patients diagnosed as MGD by 2010 diagnostic criteria Tear film lipid layer thickness is less than 75nm by LipiView
Key exclusion criteria	Subjects without written informed consent Obvious ocular surface or eyelid disease Contact lens wear Punctal plug insertion
Target sample size	50

Research contact person
Name of lead principal investigator	Reiko Arita
Organization	Itoh Clinic
Division name	Ophthalmology
Address	626-11, Minaminakano. Minuma-ku, Saitama City
TEL	048-686-5588
Email	ritoh@za2.so-net.ne.jp

Public contact
Name of contact person	Reiko Arita
Organization	Itoh Clinic
Division name	Ophthalmology
Address	626-11, Minaminakano. Minuma-ku, Saitama City
TEL	048-686-5588
Homepage URL
Email	ritoh@za2.so-net.ne.jp

Sponsor
Institute	Itoh Clinic
Institute
Department

Funding Source
Organization	Lid and Meibomian Gland Dysfunction Working Group
Organization
Division
Category of Funding Organization	Other
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	2017 Year 08 Month 21 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 07 Month 06 Day
Anticipated trial start date	2017 Year 08 Month 21 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	2017 Year 07 Month 11 Day
Last modified on	2017 Year 07 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032224