<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/NCT02205840</url>
  </required_header>
  <id_info>
    <org_study_id>614/1131</org_study_id>
    <nct_id>NCT02205840</nct_id>
  </id_info>
  <brief_title>A Clinical Study Evaluating the Safety and Efficacy of SI-614 Ophthalmic Solution in Patients With Dry Eye.</brief_title>
  <official_title>A Multicenter, Randomized, Double-masked and Placebo-controlled Study Evaluating the Efficacy and Safety of SI-614 Ophthalmic Solution in Patients With Dry Eye</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seikagaku Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seikagaku Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and effectiveness of SI-614 solution&#xD;
      compared with placebo solution in treating patients with dry eye.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 2/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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Corneal staining score</measure>
    <time_frame>Up to 28 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom score</measure>
    <time_frame>Up to 28 days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Dry Eye Syndromes</condition>
  <arm_group>
    <arm_group_label>SI-614</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SI-614</intervention_name>
    <description>1 drop in each eye</description>
    <arm_group_label>SI-614</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle</intervention_name>
    <description>1 drop in each eye</description>
    <arm_group_label>Placebo Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be at least 18 years of age&#xD;
&#xD;
          -  Have provided written informed consent&#xD;
&#xD;
          -  Have dry eye in both eyes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of contact lenses&#xD;
&#xD;
          -  Have an uncontrolled systemic disease&#xD;
&#xD;
          -  Have an uncontrolled psychiatric condition, or substance or alcohol abuse&#xD;
&#xD;
          -  Women who is pregnant, nursing or planning a pregnancy&#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>Andover</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <disposition_first_submitted>January 19, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>January 19, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">January 29, 2015</disposition_first_posted>
  <last_update_submitted>July 10, 2023</last_update_submitted>
  <last_update_submitted_qc>July 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2023</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>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT02205840
org study id: 614/1131
nct id: NCT02205840
lead sponsor: 
has dmc: No
The purpose of this study is to assess the safety and effectiveness of SI-614 solution
      compared with placebo solution in treating patients with dry eye.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Corneal staining score
time frame: Up to 28 days
measure: Symptom score
time frame: Up to 28 days
arm group label: SI-614
arm group type: Experimental
arm group label: Placebo Vehicle
arm group type: Placebo Comparator
intervention type: Drug
intervention name: SI-614
description: 1 drop in each eye
arm group label: SI-614
intervention type: Drug
intervention name: Vehicle
description: 1 drop in each eye
arm group label: Placebo Vehicle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca