UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Survey of Meibomian gland dysfunction
Title of the study (Brief title)	Survey of Meibomian gland dysfunction
Region	Japan

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

Objectives
Narrative objectives1	1. To evaluate the prevalence of MGD in Japanese and compare it with that in other races. 2. To evaluate the efficacy of diagnostic criteria of MGD working group in Japan. 3. To establish questionnaire for diagnosis of MGD
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

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	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years old or older Male and female
Key exclusion criteria	Patients with surgical history in the internal eye (including laser therapy) within 3 months prior to initiation of the clinical research.
Target sample size	500

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	Published
URL releasing results
Results
Other related information	Subjects are consecutive patients who are scheduled to undergo cataract surgery at Inouye eye hospital. Subjects undergo questionnaire for dry eye and MGD, slit-lamp examination, tear breakup time, meibography, and Schirmer test. In a population-based study, the prevalence of MGD was 31%.

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=R000021423