<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/NCT01670357</url>
  </required_header>
  <id_info>
    <org_study_id>DA6034_DES_II</org_study_id>
    <nct_id>NCT01670357</nct_id>
  </id_info>
  <brief_title>Phase II Study of DA-6034 Eye Drops in Dry Eye Syndrome</brief_title>
  <acronym>DES</acronym>
  <official_title>Placebo Controlled, Dose-Response, Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of DA-6034 Eye Drops in Patients With Dry Eye Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dong-A ST Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dong-A ST Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to determine the efficacy and safety of 3% or 5% DA-6034 eye drops compared&#xD;
      with placebo in dry eye syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible subjects are randomly assigned to receive 3% DA-6034, 5% DA-6034 or Placebo. This&#xD;
      study is conducted for 6 weeks(Run-in Period 2 weeks + Treatment Period 4 weeks).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline of Fluorescein Corneal Staining(FCS) score</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change from baseline means the change between 0 weeks and 4 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of Tear Break-Up Time(TBUT)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change from baseline means the change between 0 weeks and 4 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change from baseline means the change between 0 weeks and 4 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of Schirmer Test I score</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change from baseline means the change between 0 weeks and 4 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of Ocular Surface Disease Index(OSDI) score</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change from baseline means the change between 0 weeks and 4 weeks.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Dry Eye Syndrome</condition>
  <arm_group>
    <arm_group_label>DA-6034 Low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DA-6034 3%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DA-6034 High dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DA-6034 5%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>DA-6034 Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DA-6034 3%</intervention_name>
    <description>Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks</description>
    <arm_group_label>DA-6034 Low dose</arm_group_label>
    <other_name>DA-6034 Low dose</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DA-6034 5%</intervention_name>
    <description>Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks</description>
    <arm_group_label>DA-6034 High dose</arm_group_label>
    <other_name>DA-6034 High dose</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DA-6034 Placebo</intervention_name>
    <description>Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age≥20&#xD;
&#xD;
          2. Dry eye symptoms(irritation, foreign body sensation, burning, mucus discharge,&#xD;
             blurring, itching, photophobia, tird or heavy feeling, pain) for more than 6 months&#xD;
&#xD;
          3. Fluorescein corneal staining score ≥ 4 and Schirmer test I ≤ 7mm in same eye&#xD;
&#xD;
          4. Corrected vision ≥ 0.2 in both eye&#xD;
&#xD;
          5. Have given a written, informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Ocular disorder that may confound interpretation of study results&#xD;
&#xD;
          2. Current treatment for glaucoma or IOP over 25mmHg&#xD;
&#xD;
          3. Ocular surgery history within 1 year&#xD;
&#xD;
          4. Other malignancy history or uncontrolled severe disease within 5 years&#xD;
&#xD;
          5. Use of systemic immunosuppressive therapies within 3 months&#xD;
&#xD;
          6. Use of opthalmic cyclosporin, opthalmic steroid within 4 weeks&#xD;
&#xD;
          7. Received any other investigational drugs within 4 weeks&#xD;
&#xD;
          8. Subjects who are willing to wear contact lenses during study participation&#xD;
&#xD;
          9. Pregnant or lactating women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ManSoo Kim, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul St. Mary's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul St.Mary's hospital</name>
      <address>
        <city>Seoul</city>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>January 19, 2012</study_first_submitted>
  <study_first_submitted_qc>August 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>September 29, 2014</last_update_submitted>
  <last_update_submitted_qc>September 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dry Eye Syndrome</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/NCT01670357
org study id: DA6034_DES_II
nct id: NCT01670357
lead sponsor: 
has dmc: No
This study is to determine the efficacy and safety of 3% or 5% DA-6034 eye drops compared
      with placebo in dry eye syndrome.
Eligible subjects are randomly assigned to receive 3% DA-6034, 5% DA-6034 or Placebo. This
      study is conducted for 6 weeks(Run-in Period 2 weeks + Treatment Period 4 weeks).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change from baseline of Fluorescein Corneal Staining(FCS) score
time frame: 4 weeks
description: Change from baseline means the change between 0 weeks and 4 weeks.
measure: Change from baseline of Tear Break-Up Time(TBUT)
time frame: 4 weeks
description: Change from baseline means the change between 0 weeks and 4 weeks.
measure: Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score
time frame: 4 weeks
description: Change from baseline means the change between 0 weeks and 4 weeks.
measure: Change from baseline of Schirmer Test I score
time frame: 4 weeks
description: Change from baseline means the change between 0 weeks and 4 weeks.
measure: Change from baseline of Ocular Surface Disease Index(OSDI) score
time frame: 4 weeks
description: Change from baseline means the change between 0 weeks and 4 weeks.
arm group label: DA-6034 Low dose
arm group type: Experimental
description: DA-6034 3%
arm group label: DA-6034 High dose
arm group type: Experimental
description: DA-6034 5%
arm group label: Placebo
arm group type: Placebo Comparator
description: DA-6034 Placebo
intervention type: Drug
intervention name: DA-6034 3%
description: Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
arm group label: DA-6034 Low dose
other name: DA-6034 Low dose
intervention type: Drug
intervention name: DA-6034 5%
description: Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
arm group label: DA-6034 High dose
other name: DA-6034 High dose
intervention type: Drug
intervention name: DA-6034 Placebo
description: Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
arm group label: Placebo
other name: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: ManSoo Kim, M.D.
role: Principal Investigator
affiliation: Seoul St. Mary's Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Syndrome