<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04448223</url>
  </required_header>
  <id_info>
    <org_study_id>A71_04GLC1915</org_study_id>
    <nct_id>NCT04448223</nct_id>
  </id_info>
  <brief_title>A Clinical Study to Evaluate the Efficacy and Safety of CKD-351</brief_title>
  <official_title>Multi Center, Randomized, Open-label, Active Controlled, Phase 2 Trial, Proof Of Concept Study to Evaluate the Efficacy and Safety of CKD-351 in Primary Open Angle Glaucoma or Ocular Hypertension Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chong Kun Dang Pharmaceutical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chong Kun Dang Pharmaceutical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate efficacy and safety of CKD-351&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multi center, Randomized, Open-label, Active controlled, Phase 2 trial, Proof Of Concept&#xD;
      Study to evaluate the efficacy and safety of CKD-351 in primary open angle glaucoma or ocular&#xD;
      hypertension patients&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 11, 2020</start_date>
  <completion_date type="Anticipated">December 5, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 5, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in mean intraocular pressure for efficacy measurement</measure>
    <time_frame>Baseline, 4 weeks</time_frame>
    <description>Change in mean intraocular pressure at 4 weeks compared to baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in mean intraocular pressure for efficacy measurement</measure>
    <time_frame>Baseline, 2 weeks</time_frame>
    <description>Change in mean intraocular pressure at 2 weeks compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in intraocular pressure for efficacy measurement</measure>
    <time_frame>Baseline, 2 weeks, 4 weeks</time_frame>
    <description>Intraocular pressure by each measurement time</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Primary Open Angle Glaucoma</condition>
  <condition>Ocular Hypertension</condition>
  <arm_group>
    <arm_group_label>CKD-351</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CKD-351</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Latanoprost+Dorzolamide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Latanoprost(50ul/ml) Dorzolmamide(20mg/ml)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CKD-351</intervention_name>
    <description>Latanoprost (25ug/ml), Dorzolamide (20mg/ml), twice a day</description>
    <arm_group_label>CKD-351</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Latanoprost+Dorzolmamide</intervention_name>
    <description>Latanoprost(50ug/ml) , once a day Dorzolmamide(20mg/ml), threetimes a day</description>
    <arm_group_label>Latanoprost+Dorzolamide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. More than the age of 19 years old&#xD;
&#xD;
          2. Subjects who has primary open-angle glaucoma or ocular hypertension&#xD;
&#xD;
          3. Subjects who sign on an informed consent form willingly&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with intraocular pressure ≥ 35 mmHg at Visit 1 or Visit 2 (AM 09:00)&#xD;
&#xD;
          2. Subjects with a maximum corrected visual acuity ≤ 0.3 in the selected evaluation eye&#xD;
             at Visit 1 or Visit 2&#xD;
&#xD;
          3. Subjects who were diagnosed as below&#xD;
&#xD;
               -  Aphakia&#xD;
&#xD;
               -  Intraocular lens&#xD;
&#xD;
               -  Acute or Chronic Closed-Angle Glaucoma&#xD;
&#xD;
               -  Secondary Glaucoma&#xD;
&#xD;
          4. Subjects with ocular inflammation or infection within the last 3 months&#xD;
&#xD;
          5. Subjects with significant history of ocular trauma during the last 6 months or who&#xD;
             underwent surgical opthalmic surgery&#xD;
&#xD;
          6. Subjects who received topical or systemic steroids within the last 1 month.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>KiHo Park, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>KiHo Park</last_name>
    <phone>+82-10-3458-3172</phone>
    <email>kihopark@snu.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>KiHo Park, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Primary Open-angle Glaucoma</keyword>
  <keyword>Ocular Hypertension</keyword>
  <keyword>CKD-351</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</mesh_term>
    <mesh_term>Ocular Hypertension</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Latanoprost</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04448223
org study id: A71_04GLC1915
nct id: NCT04448223
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate efficacy and safety of CKD-351
Multi center, Randomized, Open-label, Active controlled, Phase 2 trial, Proof Of Concept
      Study to evaluate the efficacy and safety of CKD-351 in primary open angle glaucoma or ocular
      hypertension patients
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in mean intraocular pressure for efficacy measurement
time frame: Baseline, 4 weeks
description: Change in mean intraocular pressure at 4 weeks compared to baseline
measure: Change in mean intraocular pressure for efficacy measurement
time frame: Baseline, 2 weeks
description: Change in mean intraocular pressure at 2 weeks compared to baseline
measure: Changes in intraocular pressure for efficacy measurement
time frame: Baseline, 2 weeks, 4 weeks
description: Intraocular pressure by each measurement time
arm group label: CKD-351
arm group type: Experimental
description: CKD-351
arm group label: Latanoprost+Dorzolamide
arm group type: Active Comparator
description: Latanoprost(50ul/ml) Dorzolmamide(20mg/ml)
intervention type: Drug
intervention name: CKD-351
description: Latanoprost (25ug/ml), Dorzolamide (20mg/ml), twice a day
arm group label: CKD-351
intervention type: Drug
intervention name: Latanoprost+Dorzolmamide
description: Latanoprost(50ug/ml) , once a day Dorzolmamide(20mg/ml), threetimes a day
arm group label: Latanoprost+Dorzolamide
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: KiHo Park, MD
role: Principal Investigator
affiliation: Seoul National University Hospital
last name: KiHo Park
phone: +82-10-3458-3172
email: kihopark@snu.ac.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Ocular Hypertension
mesh term: Hypertension
mesh term: Latanoprost
sharing ipd: No