UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dry Eye Cross-sectional, Multicenter Study in Korea (DECS-K)
Title of the study (Brief title)	Dry Eye Cross-sectional Study in Korea (DECS-K)
Region	Asia(except Japan)

Condition
Condition	Dry eye
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the status of patients with dry eye who visit medical institutions in Korea, and to evaluate the proportion of patients diagnosed with dry eye by diagnostic criteria proposed by Asia Dry Eye Society (ADES) among patients diagnosed with dry eye by diagnostic criteria in Korea and at the same time, to obtain evidence for improvement of the qualities of future dry eye diagnosis and medical care.
Basic objectives2	Others
Basic objectives -Others	To investigate the status of patients with dry eye
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) Percent of the subjects who satisfy the ADES dry eye diagnostic criteria 2) Mean values and percent of test/observation results 3) Subject background (including sex, age, history of contact lens wearing, ocular disease and ocular surgeries) 4) Percent of types and severity levels of dry eye 5) Correlation between dry eye types and severity levels 6) First-treatment difference among dry eye types 7) Correlation between the scores of questionnaires and test/observation results 8) Correlation between OSDI scores and DEQS scores
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	19 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Those aged 19 years or over (regardless of sex) 2) Outpatients 3) Those diagnosed with dry eye based on the dry eye diagnostic criteria in Korea
Key exclusion criteria	1) Those who have been diagnosed with dry eye and treated for dry eye within 2 weeks before study participation (4 weeks in the case of corticosteroid eye drops and cyclosporine eye drops). 2) Those with a history of hypersensitivity to fluorescein 3) Those who the principal investigator and/or subinvestigator consider ineligible for the study
Target sample size	160

Research contact person
Name of lead principal investigator	Hyo Myung Kim
Organization	Korea University Anam Hospital
Division name	Department of ophthalmology
Address	Inchon-ro 73 Seongbuk-gu Seoul, 02841, Korea
TEL	+82-2-920-5366
Email	inerby1@hanmail.net

Public contact
Name of contact person	Su-Yeon Kang
Organization	Korea University Anam Hospital
Division name	Department of ophthalmology
Address	Inchon-ro 73 Seongbuk-gu Seoul, 02841, Korea
TEL	+82-2-920-5366
Homepage URL
Email	inerby1@hanmail.net

Sponsor
Institute	Asia Dry Eye Society
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

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 30 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 04 Month 28 Day
Anticipated trial start date	2016 Year 09 Month 30 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 investigate dry eye diagnosis and treatment

Management information
Registered date	2016 Year 08 Month 16 Day
Last modified on	2018 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027228