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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023643
Receipt No. R000027228
Scientific Title Dry Eye Cross-sectional, Multicenter Study in Korea (DECS-K)
Date of disclosure of the study information 2016/09/30
Last modified on 2018/04/17

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Basic information
Public title Dry Eye Cross-sectional, Multicenter Study in Korea (DECS-K)
Acronym Dry Eye Cross-sectional Study in Korea (DECS-K)
Scientific Title Dry Eye Cross-sectional, Multicenter Study in Korea (DECS-K)
Scientific Title:Acronym 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
1st name
Middle name
Last name Hyo Myung Kim
Organization Korea University Anam Hospital
Division name Department of ophthalmology
Zip code
Address Inchon-ro 73 Seongbuk-gu Seoul, 02841, Korea
TEL +82-2-920-5366
Email inerby1@hanmail.net

Public contact
Name of contact person
1st name
Middle name
Last name Su-Yeon Kang
Organization Korea University Anam Hospital
Division name Department of ophthalmology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2016 Year 04 Month 28 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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