<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/NCT01675570</url>
  </required_header>
  <id_info>
    <org_study_id>CTD1201</org_study_id>
    <nct_id>NCT01675570</nct_id>
  </id_info>
  <brief_title>A Study of RX-10045 in the Treatment of Dry Eye Disease</brief_title>
  <official_title>A Phase II, Multi-Center, Randomized, Placebo-Controlled, Double-Masked Study of RX-10045 (0.09%) in the Treatment of Dry Eye Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>C.T. Development America, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>C.T. Development America, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to assess the efficacy, tolerability and safety of&#xD;
      RX-10045 Ophthalmic Solution in patients with Dry Eye Disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Corneal staining</measure>
    <time_frame>Baseline to day 28</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Worst symptom score</measure>
    <time_frame>Baseline to day 28</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ocular discomfort symptom score</measure>
    <time_frame>Baseline to day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tear film break-up time</measure>
    <time_frame>Baseline to day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual-related function subscale of Ocular Surface Disease Index score</measure>
    <time_frame>Baseline to day 28</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Dry Eye Syndrome</condition>
  <arm_group>
    <arm_group_label>RX-10045 active arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RX-10045 Opththalmic Solution, 0.09%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle for RX-10045 arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle of RX-10045 Ophthalmic Solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RX-10045</intervention_name>
    <description>One drop of RX-10045 ophthalmic solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days.</description>
    <arm_group_label>RX-10045 active arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle for RX-10045</intervention_name>
    <description>One drop of RX-10045 placebo solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days.</description>
    <arm_group_label>Vehicle for RX-10045 arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Have a patient reported history of dry eye in both eyes&#xD;
&#xD;
          2. Presence of dry eye symptoms&#xD;
&#xD;
          3. Presence of dry eye signs, destabilized tear film break-up time and corneal staining&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known contraindications or sensitivities to study medication or its components&#xD;
&#xD;
          2. Any ocular condition that, in the opinion of the investigator, could affect the&#xD;
             subject's safety or trial parameters&#xD;
&#xD;
          3. Use of disallowed medication during the period indicated prior to the enrollment or&#xD;
             during the study&#xD;
&#xD;
          4. Be a female who is currently pregnant, planning a pregnancy, lactating, or not using a&#xD;
             medically acceptable form of birth control&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gail Torkildsen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Andover Eye Associates</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Andover Eye Associates</name>
      <address>
        <city>Andover</city>
        <state>Massachusetts</state>
        <zip>01810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>February 7, 2013</last_update_submitted>
  <last_update_submitted_qc>February 7, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 8, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>RX-10045</keyword>
  <keyword>Dry Eye Disease</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>Eye Diseases</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/NCT01675570
org study id: CTD1201
nct id: NCT01675570
lead sponsor: 
has dmc: Yes
The primary purpose of this study is to assess the efficacy, tolerability and safety of
      RX-10045 Ophthalmic Solution in patients with Dry Eye Disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Corneal staining
time frame: Baseline to day 28
measure: Worst symptom score
time frame: Baseline to day 28
measure: Ocular discomfort symptom score
time frame: Baseline to day 28
measure: Tear film break-up time
time frame: Baseline to day 28
measure: Visual-related function subscale of Ocular Surface Disease Index score
time frame: Baseline to day 28
arm group label: RX-10045 active arm
arm group type: Experimental
description: RX-10045 Opththalmic Solution, 0.09%
arm group label: Vehicle for RX-10045 arm
arm group type: Placebo Comparator
description: Vehicle of RX-10045 Ophthalmic Solution
intervention type: Drug
intervention name: RX-10045
description: One drop of RX-10045 ophthalmic solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days.
arm group label: RX-10045 active arm
intervention type: Drug
intervention name: Vehicle for RX-10045
description: One drop of RX-10045 placebo solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days.
arm group label: Vehicle for RX-10045 arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gail Torkildsen, MD
role: Principal Investigator
affiliation: Andover Eye Associates
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Eye Diseases