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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2018/06/03
    • Registered Date : 2018/08/28
    • Last Updated Date : 2018/08/15
Background Information
1.Background  
CRIS Registration Number KCT0003134 
Unique Protocol ID H-1402-058-567 
Public/Brief Title Safety and efficacy of Diquas eye drops 3% 
Scientific Title Post marketing surveillance on safety and efficacy of Diquas eye drops 3% in Korean patients in accordance with 'Regulation for re-examination of new drugs, etc."  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol No
Registered at Other Registry No
Healthcare Benefit
Approval Status
Not applicable
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
Board Approval Status Submitted approval 
Board Approval Number H-1402-058-567 
Approval Date 2014-02-25 
Institutional Review Board  
- Name Seoul National University Hospital Instituttional Review Board  
- Address 103, Daehak-ro, Jongno-gu, Seoul 
- Telephone 02-2072-0694 
Data Monitoring Committee    
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name Joo Youn Oh 
- Title Dr. 
- Telephone +82-2-2072-0027 
- Affiliation Seoul National University Hospital 
- Address 101, Daehak-ro, Jongno-gu, Seoul, Korea. 03080 
Contact Person for Public Queries
- Name Joo Youn Oh 
- Title Dr. 
- Telephone +82-2-2072-0027 
- Affiliation Seoul National University Hospital 
- Address 101, Daehak-ro, Jongno-gu, Seoul, Korea. 03080 
Contact Person for Updating Information
- Name Joo Youn Oh 
- Title Dr. 
- Telephone +82-2-2072-0027 
- Affiliation Seoul National University Hospital 
- Address 101, Daehak-ro, Jongno-gu, Seoul, Korea. 03080 
Status
4. Status Status  
Study Site Single
Overall Recruitment Status Completed  
Date of First Enrollment 2014-03-11 , Actual
Target Number of Participant 70
Primary Completion Date 2017-03-14 , Actual
Study Completion Date 2017-03-14 , Actual
Recruitment Status by Participating Study Site 1 
- Name of Study Site Seoul National University Hospital 
- Recruitment Status Completed  
- Date of First Enrollment 2014-03-11 , Actual
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Seoul National University Hospital 
- Organization Type Medical Institute  
- Project ID 0820140060 
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Seoul National University Hospital 
- Organization Type Medical Institute  
Study Summary
7. Study Summary  
Lay Summary To investigate the efficacy and safety of Diquas 3% ophthalmic solution in Korean patients with dry eye syndrome  
Study Design 정보
8. Study Design  
Study Type Interventional Study 
Study Purpose Treatment
Phase Not applicable 
Intervention Model Single Group  
Blinding/Masking Open 
Allocation RCT 
Intervention Type Drug  
Intervention Description Diquas 3% ophthalmic solution, six times a day, for more than 4 weeks, topical eye drop application  
Number of Arms
Arm 1 Arm Label Korean patients with dry eye syndrome 
Target Number of Participant 70 
Arm Type Experimental 
Arm Description Diquas 3% ophthalmic solution, six times a day, for more than 4 weeks, topical eye drop application 
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Diseases of the eye and adnexa
 
Rare Disease No
Inclusion
Criteria
Gender Both 
Age No Limit ~ No Limit
Description Patients with dry eye syndrome  
Exclusion Criteria None  
Healthy Volunteers No
Outcome Measure(s) Information
10. Outcome Measure(s)  
Type of Primary Outcome /Safety/Efficacy 
Primary Outcome(s) 1 
- Outcome Ocular surface staining score and tear film breakup time 
- Timepoint 4 weeks after instillation 
Secondary Outcome(s) 1 
- Outcome Subjective dry eye symptom 
- Timepoint 4 weeks after instillation 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd No
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement Yes 
Time of Sharing 2018-10
Way of Sharing Other
(Paper publication)