<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/NCT03762369</url>
  </required_header>
  <id_info>
    <org_study_id>171GLC18006</org_study_id>
    <nct_id>NCT03762369</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, Double-blind, Active Controlled, Parallel Design, Phase 3 Trial 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, Double-blind, Active controlled, Parallel design, Phase 3 trial to&#xD;
      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>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 7, 2018</start_date>
  <completion_date type="Anticipated">May 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2022</primary_completion_date>
  <phase>Phase 3</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in mean intraocular pressure at 12 weeks compared to baseline</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in mean intraocular pressure at 4 weeks, 8weeks compared to baseline</measure>
    <time_frame>Baseline, 4 weeks, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in intraocular pressure by measurement time</measure>
    <time_frame>4 weeks, 8 weeks, 12 weeks</time_frame>
    <description>IOP variation by measurement time</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety assessed by number of participants with treatment-related adverse events</measure>
    <time_frame>up to 24 weeks</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">384</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>Latanoprost+D930</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Latanoprost</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>D930</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CKD-351</intervention_name>
    <description>twice a day</description>
    <arm_group_label>CKD-351</arm_group_label>
    <other_name>Latanoprost+D930</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Latanoprost</intervention_name>
    <description>once a day</description>
    <arm_group_label>Latanoprost</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>D930</intervention_name>
    <description>three times a day</description>
    <arm_group_label>CKD-351</arm_group_label>
    <arm_group_label>D930</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo of CKD-351</intervention_name>
    <description>once a day</description>
    <arm_group_label>Latanoprost</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo of CKD-351</intervention_name>
    <description>twice a day</description>
    <arm_group_label>D930</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo of D930</intervention_name>
    <description>three times a day</description>
    <arm_group_label>Latanoprost</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 IOP(Intraocular Pressure) ≥35 mmHg at Visit 1 and Visit 2 (AM 09:00) at&#xD;
             more than one eye&#xD;
&#xD;
          2. Subjects with a maximum corrected visual acuity ≤ 0.3 in the selected evaluation eye&#xD;
             at Visit 2&#xD;
&#xD;
          3. Subjects who were diagnosed as below with monocular or both eye&#xD;
&#xD;
               -  Acute or Chronic Closed-Angle Glaucoma&#xD;
&#xD;
               -  Secondary Glaucoma&#xD;
&#xD;
               -  Pseudoexfoliation Glaucoma&#xD;
&#xD;
               -  Neovascular Glaucoma&#xD;
&#xD;
               -  Aphakia&#xD;
&#xD;
               -  Phacocyst capsular torn intraocular lens&#xD;
&#xD;
          4. Subjects with significant eye symptoms/signs(Abscesses, diplopia) or severe visual&#xD;
             field impairment(Mean Deviation ≥ -25dB)&#xD;
&#xD;
          5. Subjects with severe dry eye syndrome or progressive retinal disease(Retinal&#xD;
             degeneration, Diabetic retinopathy, Retinal detachment, Macular edema)&#xD;
&#xD;
          6. Subjects with inflammatory/infectious eye disease and active eye disease within the&#xD;
             last 3 months&#xD;
&#xD;
          7. Subjects who have medical history following&#xD;
&#xD;
               -  Subjects with significant history of ocular trauma during the last 6 months, or&#xD;
                  who underwent surgical ophthalmic surgery&#xD;
&#xD;
               -  Subjects who received topical or systemic steroids within the last 1 months&#xD;
&#xD;
          8. Subjects who wore need to wear contact lenses during the study&#xD;
&#xD;
          9. Women who are nursing, pregnant or planning pregnancy during the study&#xD;
&#xD;
         10. Subjects with bronchial asthma or history&#xD;
&#xD;
         11. Subjects with severe renal impairment (creatinine clearance &lt;30 ml / min at screening)&#xD;
             or hyperchloremic acidosis&#xD;
&#xD;
         12. Subjects who have received any other investigational product within 1 month prior to&#xD;
             randomization&#xD;
&#xD;
         13. Impossible subjects who participate in clinical trial by investigator's decision&#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</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hosipital</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 Hosipital</name>
      <address>
        <city>Seoul</city>
        <state>Jongno</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>November 30, 2018</last_update_submitted>
  <last_update_submitted_qc>November 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2018</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/NCT03762369
org study id: 171GLC18006
nct id: NCT03762369
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, Double-blind, Active controlled, Parallel design, Phase 3 trial 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: Triple (Participant, Care Provider, Investigator)
measure: Change in mean intraocular pressure at 12 weeks compared to baseline
time frame: Baseline, 12 weeks
measure: Change in mean intraocular pressure at 4 weeks, 8weeks compared to baseline
time frame: Baseline, 4 weeks, 8 weeks
measure: Changes in intraocular pressure by measurement time
time frame: 4 weeks, 8 weeks, 12 weeks
description: IOP variation by measurement time
measure: Safety assessed by number of participants with treatment-related adverse events
time frame: up to 24 weeks
arm group label: CKD-351
arm group type: Experimental
description: Latanoprost+D930
arm group label: Latanoprost
arm group type: Active Comparator
arm group label: D930
arm group type: Active Comparator
intervention type: Drug
intervention name: CKD-351
description: twice a day
arm group label: CKD-351
other name: Latanoprost+D930
intervention type: Drug
intervention name: Latanoprost
description: once a day
arm group label: Latanoprost
intervention type: Drug
intervention name: D930
description: three times a day
arm group label: CKD-351
arm group label: D930
intervention type: Drug
intervention name: Placebo of CKD-351
description: once a day
arm group label: Latanoprost
intervention type: Drug
intervention name: Placebo of CKD-351
description: twice a day
arm group label: D930
intervention type: Drug
intervention name: Placebo of D930
description: three times a day
arm group label: Latanoprost
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: KiHo Park
role: Principal Investigator
affiliation: Seoul National University Hosipital
last name: KiHo Park
phone: 82-10-3458-3172
email: kihopark@snu.ac.kr
facility: 
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