Status Approved
First Submitted Date
2018/06/03
Registered Date
2018/08/28
Last Updated Date
2018/08/15
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
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 |
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 |
Institutional Review Board Address | 103, Daehak-ro, Jongno-gu, Seoul |
Institutional Review Board Telephone | 02-2072-0694 |
Data Monitoring Committee |
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 |
4. 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 | Seoul National University Hospital | |
Recruitment Status | Completed | |
Date of First Enrollment | 2014-03-11 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Seoul National University Hospital |
Organization Type | Medical Institute |
Project ID | 0820140060 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Seoul National University Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | To investigate the efficacy and safety of Diquas 3% ophthalmic solution in Korean patients with dry eye syndrome |
---|
8. Study Design
Study Type | Interventional Study |
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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 | 1 |
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 |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (H00-H59)Diseases of the eye and adnexa (H04.11)Dry eye syndrome |
---|---|
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age No Limit~No Limit |
|
Description Patients with dry eye syndrome |
|
Exclusion Criteria |
None |
Healthy Volunteers | No |
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 |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
---|---|
Time of Sharing | 2018. 10 |
Way of Sharing | Other
(Paper publication) |
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