UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of efficacy of diquafosol sodium eyedrop
Title of the study (Brief title)	Evaluation of efficacy of diquafosol sodium eyedrop
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy of diquafosol sodium ophthalmic solution for the Dry Eye patients with MGD
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Symptoms 2. Slit lamp 3. Tear film breakup time 4. Meibography 5.Tear volume , Tear thickness
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Diquafosol sodium ophthalmic solution
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Over 20years old 2. Male and Female 3. Patients diagnosed as dry eye 4. Patients with MGD
Key exclusion criteria	1. atients who use dry eye or MGD treatment within 2 weeks before a study starts. 2. Patient who have a previous history of treatment intended to become obstructed lacrimal puncta. 3. Patients who need to use eyedrops other than test drugs during a study. 4. Patients who have anatomically and functionally abnormal eyelid. 5. Patients with surgical history in the internal eye (including laser therapy) within 3 months prior to initiation of the clinical research. 6. Patients who have a previous allergy to drugs that they use during a study. 7. Patients who have any other reasons that causes the study doctor to deem a subject unsuitable for the study
Target sample size	30

Research contact person
Name of lead principal investigator	Shiro Amano
Organization	Inouye Eye Hospital
Division name	Ophthalmology
Address	4-3 Kanda Surugadai, Chiyoda-Tokyo, Japan
TEL	03-3295-0911
Email	amanoshiro1126@gmail.com

Public contact
Name of contact person	Shiro Amano
Organization	Inouye Eye Hospital
Division name	Ophthalmology
Address	4-3 Kanda Surugadai, Chiyoda-Tokyo, Japan
TEL	03-3295-0911
Homepage URL
Email	amanoshiro1126@gmail.com

Sponsor
Institute	Inouye Eye Hospital
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
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	医療法人社団　済安堂 お茶の水・井上眼科クリニック（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 08 Day
Anticipated trial start date	2015 Year 06 Month 22 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	2015 Year 07 Month 31 Day
Last modified on	2017 Year 07 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021425