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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."

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

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    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

    Institutional Review Board Information
    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 Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    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

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    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

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Seoul National University Hospital
    Organization Type Medical Institute
    Project ID 0820140060
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Seoul National University Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    To investigate the efficacy and safety of Diquas 3% ophthalmic solution in Korean patients with dry eye syndrome
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    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 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

    Subject Eligibility Information
    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)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    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

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2018. 10
    Way of Sharing Other
    (Paper publication)
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