UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Epidemiological study related to ocular surface factors for all residents in Takushima island, Hirado, Nagasaki
Title of the study (Brief title)	Epidemiological study related to ocular surface factors in Takushima island
Region	Japan

Condition
Condition	Ocular surface diseases
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the epidemiology of ocular surface related factors
Basic objectives2	Others
Basic objectives -Others	epidemiological study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	questionnaire related to dry eye questionnaire related to food questionnaire related to life tearfilm-related factors ocular surface-related factors
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	6 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Subjects who agree to the joining to the study based on the informed consent (2) Subjects less than 20 y-o whose parent(s) agree to joining to the study
Key exclusion criteria	(1) People who cannot set their chin on the slitlamp microscope (2) People who cannot communicate regularly (3) People whom doctors judge to be inadequate to join the study
Target sample size	652

Research contact person
Name of lead principal investigator	Reiko Arita
Organization	Lid and Meibomian gland working group
Division name	Division for epidemiological study in Takushima island
Address	626-11 Minaminakano, minuma-ku, Saitama, Saitama
TEL	048-686-5588
Email	arita.reiko@gmail.com

Public contact
Name of contact person	Reiko Arita
Organization	Lid and Meibomian gland working group
Division name	Division for epidemiological study in Takushima island
Address	626-11 Minaminakano, minuma-ku, Saitama, Saitama
TEL	048-686-5588
Homepage URL
Email	arita.reiko@gmail.com

Sponsor
Institute	Lid and Meibomian gland working group
Institute
Department

Funding Source
Organization	Lid and Meibomian gland working group
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

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 01 Day
Anticipated trial start date	2017 Year 08 Month 01 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	To observe the details related to the dry eye factors

Management information
Registered date	2017 Year 07 Month 20 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=R000032406