<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/NCT01692145</url>
  </required_header>
  <id_info>
    <org_study_id>KCT1204</org_study_id>
    <nct_id>NCT01692145</nct_id>
  </id_info>
  <brief_title>A Parallel Group Phase II Study of KCT-0809 in Patients With Dry Eye Syndromes</brief_title>
  <official_title>A Randomized, Double Blind, Placebo Controlled, Parallel Group Phase II Study of KCT-0809 in Patients With Dry Eye Syndromes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kissei Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kissei Pharmaceutical Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to&#xD;
      placebo in patients with dry eye syndromes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Score of the Corneal conjunctival staining</measure>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <condition>Dry Eye Syndromes</condition>
  <arm_group>
    <arm_group_label>KCT-0809 ophtalmic solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KCT-0809</intervention_name>
    <arm_group_label>KCT-0809 ophtalmic solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Corneal and conjunctival damage&#xD;
&#xD;
          -  Insufficiency of lacrimal secretion&#xD;
&#xD;
          -  Ocular symptom&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe ophthalmic disorder&#xD;
&#xD;
          -  Punctual plugs or surgery for occlusion of the lacrimal puncta&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Japan</name>
      <address>
        <city>Tokyo and Other Japanese City</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>May 29, 2014</last_update_submitted>
  <last_update_submitted_qc>May 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 30, 2014</last_update_posted>
  <keyword>Dry eye syndromes</keyword>
  <keyword>Corneal diseases</keyword>
  <keyword>Conjunctival diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT01692145
org study id: KCT1204
nct id: NCT01692145
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to
      placebo in patients with dry eye syndromes.
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Score of the Corneal conjunctival staining
arm group label: KCT-0809 ophtalmic solution
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: KCT-0809
arm group label: KCT-0809 ophtalmic solution
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Japan
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Syndrome