UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Systane Balance eye drop on tear lipid layer thickness with dry eye patients accompanied with meibomian gland dysfunction
Title of the study (Brief title)	Efficacy of Systane Balance on lipid layer with meibomian gland dysfunction
Region	Japan

Condition
Condition	Dry eye accompanied with meibomian gland dysfunction
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the efficacy of Sytaine Balance onto the lipid layer thickness, followed by tear film stability with dry eye patients
Basic objectives2	Others
Basic objectives -Others	Changes of lipid layer thickness
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Lipid layer thickness (pre, 15 min, 30 min, 60 min)
Key secondary outcomes	Symptoms,tear film breakup time, meiboscore, Schirmer test, tear meniscus height, non-invasive breakup time

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	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Systaine Balance eye drop/artificial tears 4 times a day for 28 days
Interventions/Control_2	artificial tears 4 times a day for 28 days
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Dry eye accompanied with meibomian gland dysfunction
Key exclusion criteria	Other ocular diseases, the history of ocular surgery within 3 months
Target sample size	15

Research contact person
Name of lead principal investigator	Reiko Arita
Organization	Itoh Clinic
Division name	Ophthalmology
Address	626-11, Minaminakano, Minuma-ku, Saitama City, Saitama
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,
TEL	048-686-5588
Homepage URL	http://www.itoh-clinic.com/
Email	arita.reiko@gmail.com

Sponsor
Institute	Itoh Clinic Department of Ophthalmology
Institute
Department

Funding Source
Organization	None
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	伊藤医院

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 13 Day
Anticipated trial start date	2016 Year 06 Month 17 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 15 Day
Last modified on	2018 Year 03 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026205