UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation to the effects on the tear film lipid layer of 3% Diquafosol Sodium ophthalmic solution for Dry Eye patients with Meibomian gland dysfunction.
Title of the study (Brief title)	Effects of 3% Diquafosol Sodium ophthalmic solution for Dry Eye patients with MGD.
Region	Japan

Condition
Condition	Dry eye patients with Meibomian gland dysfunction
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of 3% Diquafosol Sodium ophthalmic solution to the dry eye with MGD Comparison to consider the artificial tears the change over time in the tear film lipid layer thickness by 3% Diquafosol Sodium ophthalmic solution
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Tear film lipid layer thickness Tear film meniscus Symptoms Superficial punctate keratopathy Tear film breakup time Meibography meiboscore Tear volume
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	3% Diquafosol sodium ophthalmic solution
Interventions/Control_2	Soft Santear
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	Over 20years old Male and Female Patients diagnosed as dry eye by 2006 diagnostic criteria for dry eye with Superficial punctate keratopathy. Patients with MGD Tear film lipid layer thickness is less than 75nm by LipiView
Key exclusion criteria	High degree of eye damage due to Stevens-Johnson syndrome, or ocular pemphigoid, etc. Infection of keratoconjunctival or eyelid. Obvious ocular surface or eyelid disease (eyelid congenital anomaly, entropion, ectropion) There is an allergic disease in inspection time Daily wear of contact lenses (average four days a week or more of wearing is considered every day. Wear history, from time to time the wearer is inspection day remove) Patients with surgical history in the internal eye within 3 months prior to initiation of the clinical research. History of systemic disease or eye disease can affect the tear production and function Punctal plug insertion Lipid hypersecretion from the meibomian glands Patient even if the pressure on the eyelid in Arita Meibomian Gland
Target sample size	100

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
Email	ritoh@za2.so-net.ne.jp

Sponsor
Institute	Itoh Clinic Department of Ophthalmology
Institute
Department

Funding Source
Organization	Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Itoh Clinic
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（Itoh clinic）

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 13 Day
Anticipated trial start date	2016 Year 09 Month 20 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 09 Month 13 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=R000027687