<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/NCT02981446</url>
  </required_header>
  <id_info>
    <org_study_id>01171505</org_study_id>
    <nct_id>NCT02981446</nct_id>
  </id_info>
  <brief_title>A Phase III Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost Ophthalmic Solution in Subjects With OAG or OHT</brief_title>
  <official_title>A Phase III, Randomized, Observer-Masked, Active-Controlled, Parallel-Group, Multinational and Multicenter Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution 0.002% Compared With Latanoprost Ophthalmic Solution 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension- PEONY Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Santen Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Santen Pharmaceutical Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the intraocular pressure-lowering effect and the&#xD;
      safety of DE-117 ophthalmic solution compared with Latanoprost ophthalmic solution in&#xD;
      subjects with open angle glaucoma or ocular hypertension.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">January 2019</completion_date>
  <primary_completion_date type="Actual">January 2019</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean diurnal intraocular pressure</measure>
    <time_frame>Month 3</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">370</enrollment>
  <condition>Open Angle Glaucoma or Ocular Hypertension</condition>
  <arm_group>
    <arm_group_label>DE-117 ophthalmic solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Latanoprost ophthalmic solution 0.005%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DE-117</intervention_name>
    <description>DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.</description>
    <arm_group_label>DE-117 ophthalmic solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Latanoprost ophthalmic solution</intervention_name>
    <description>Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.</description>
    <arm_group_label>Latanoprost ophthalmic solution 0.005%</arm_group_label>
    <other_name>Xalatan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with open angle glaucoma or ocular hypertension in both eyes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients at risk of progression of visual field loss&#xD;
&#xD;
          -  Patients with severe visual field defect&#xD;
&#xD;
          -  Patients with any diseases that preclude participation in this study for safety&#xD;
             reasons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>June 9, 2019</last_update_submitted>
  <last_update_submitted_qc>June 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Ophthalmic Solutions</mesh_term>
    <mesh_term>Latanoprost</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>August 2, 2023</submitted>
  </pending_results>
  <!-- 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/NCT02981446
org study id: 01171505
nct id: NCT02981446
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the intraocular pressure-lowering effect and the
      safety of DE-117 ophthalmic solution compared with Latanoprost ophthalmic solution in
      subjects with open angle glaucoma or ocular hypertension.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Mean diurnal intraocular pressure
time frame: Month 3
arm group label: DE-117 ophthalmic solution
arm group type: Experimental
arm group label: Latanoprost ophthalmic solution 0.005%
arm group type: Active Comparator
intervention type: Drug
intervention name: DE-117
description: DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
arm group label: DE-117 ophthalmic solution
intervention type: Drug
intervention name: Latanoprost ophthalmic solution
description: Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
arm group label: Latanoprost ophthalmic solution 0.005%
other name: Xalatan
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Singapore
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Ocular Hypertension
mesh term: Hypertension
mesh term: Ophthalmic Solutions
mesh term: Latanoprost
submitted: August 2, 2023