UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023643 |
|---|---|
| Receipt number | 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 12:06:38 |
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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
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
inerby1@hanmail.net
Sponsor or person
Institute
Asia Dry Eye Society
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027228
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
