<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/NCT03833388</url>
  </required_header>
  <id_info>
    <org_study_id>TOP1630-TV-05</org_study_id>
    <nct_id>NCT03833388</nct_id>
  </id_info>
  <brief_title>Study of TOP1630 for Dry Eye Syndrome</brief_title>
  <acronym>THEIA-1</acronym>
  <official_title>A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Efficacy and Safety of TOP1630 0.1% Ophthalmic Solution Compared to Placebo in Subjects With Moderate to Severe Dry Eye Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Topivert Pharma Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Topivert Pharma Ltd</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In subjects with Dry Eye Syndrome (DES):&#xD;
&#xD;
      The primary objective of this study is to confirm the efficacy of TOP1630 0.1% Ophthalmic&#xD;
      Solution TID OU compared to placebo treatment at Day 29 on pre-specified sign and symptom&#xD;
      endpoints in subjects with moderate to severe DES.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed to assess the efficacy and safety of TOP1630 ophthalmic solution in&#xD;
      subjects with Dry Eye Syndrome (DES).&#xD;
&#xD;
      Eligible subjects will be randomized double masked to either TOP1630 or placebo for a&#xD;
      duration of 28 days' treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 13, 2019</start_date>
  <completion_date type="Actual">May 14, 2019</completion_date>
  <primary_completion_date type="Actual">May 14, 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ocular grittiness 6-point (0-5) scale</measure>
    <time_frame>Day 29</time_frame>
    <description>Ocular grittiness severity assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ocular surface (all-regions) lissamine green staining score 5-point (0-4) scale each region</measure>
    <time_frame>Day 29</time_frame>
    <description>Dry Eye Syndrome ocular staining assessment. Total region score: inferior, superior, central, temporal, and nasal.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ocular discomfort 5-point (0-4) scale</measure>
    <time_frame>Day 29</time_frame>
    <description>Ocular discomfort severity assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular dryness 6-point (0-5) scale</measure>
    <time_frame>Day 29</time_frame>
    <description>Ocular dryness severity assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conjunctival lissamine green staining score 5-point (0-4) scale each region</measure>
    <time_frame>Day 29</time_frame>
    <description>Dry Eye Syndrome ocular staining assessment. Conjunctival sum score: temporal and nasal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corneal lissamine green staining score 5-point (0-4) scale each region</measure>
    <time_frame>Day 29</time_frame>
    <description>Dry Eye Syndrome ocular staining assessment. Corneal sum score: inferior, superior and central.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Worst ocular symptom 6-point (0-5) scale</measure>
    <time_frame>Day 29</time_frame>
    <description>Most severe baseline symptom from reported daily symptoms</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">202</enrollment>
  <condition>Dry Eye Syndrome</condition>
  <arm_group>
    <arm_group_label>TOP1630 Ophthalmic Solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo to TOP1630 Ophthalmic Solution</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TOP1630 0.1% Ophthalmic Solution TID OU</intervention_name>
    <description>Bilateral ocular drug administration</description>
    <arm_group_label>TOP1630 Ophthalmic Solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to TOP1630 0.1% Ophthalmic Solution TID OU</intervention_name>
    <description>Bilateral ocular drug administration</description>
    <arm_group_label>Placebo to TOP1630 Ophthalmic Solution</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be at least 18 years of age;&#xD;
&#xD;
          -  Provide written informed consent;&#xD;
&#xD;
          -  Have a reported history of dry eye;&#xD;
&#xD;
          -  Have a history of use of eye drops for dry eye symptoms;&#xD;
&#xD;
        Symptoms of dry eye syndrome including:&#xD;
&#xD;
          -  Ocular discomfort&#xD;
&#xD;
          -  Conjunctival redness&#xD;
&#xD;
          -  Tear film break up time&#xD;
&#xD;
          -  Schirmer test score&#xD;
&#xD;
        Signs of dry eye syndrome including:&#xD;
&#xD;
          -  Conjunctival staining score&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have any clinically significant slit lamp findings at entry visit ;&#xD;
&#xD;
          -  Be diagnosed with an ongoing ocular infection;&#xD;
&#xD;
          -  Have any significant ocular lesion that could interfere with assessment of safety or&#xD;
             efficacy or prevent study conduct in the opinion of the PI;&#xD;
&#xD;
          -  Have any planned ocular and/or lid surgeries over the study period;&#xD;
&#xD;
          -  Have an uncontrolled systemic disease;&#xD;
&#xD;
          -  Be a woman who is pregnant, nursing or planning a pregnancy;&#xD;
&#xD;
          -  Be a woman of childbearing potential who is not using an acceptable means of birth&#xD;
             control;&#xD;
&#xD;
          -  Have a known allergy and/or sensitivity to the test article or its components;&#xD;
&#xD;
          -  Have a condition or be in a situation which the investigator feels may put the subject&#xD;
             at significant risk, may confound the study results, or may interfere significantly&#xD;
             with the subject's participation in the study&#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>
      <name>Central Maine Eye Care</name>
      <address>
        <city>Lewiston</city>
        <state>Maine</state>
        <zip>04240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>
    <facility>
      <name>Suite 305, 775 Paramount Drive</name>
      <address>
        <city>Raynham</city>
        <state>Massachusetts</state>
        <zip>02767</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Total Eye Care</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>August 6, 2019</last_update_submitted>
  <last_update_submitted_qc>August 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 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>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharmaceutical Solutions</mesh_term>
    <mesh_term>Ophthalmic Solutions</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>February 6, 2020</submitted>
    <returned>February 19, 2020</returned>
  </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/NCT03833388
org study id: TOP1630-TV-05
nct id: NCT03833388
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
In subjects with Dry Eye Syndrome (DES):

      The primary objective of this study is to confirm the efficacy of TOP1630 0.1% Ophthalmic
      Solution TID OU compared to placebo treatment at Day 29 on pre-specified sign and symptom
      endpoints in subjects with moderate to severe DES.
This study is designed to assess the efficacy and safety of TOP1630 ophthalmic solution in
      subjects with Dry Eye Syndrome (DES).

      Eligible subjects will be randomized double masked to either TOP1630 or placebo for a
      duration of 28 days' treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Ocular grittiness 6-point (0-5) scale
time frame: Day 29
description: Ocular grittiness severity assessment
measure: Ocular surface (all-regions) lissamine green staining score 5-point (0-4) scale each region
time frame: Day 29
description: Dry Eye Syndrome ocular staining assessment. Total region score: inferior, superior, central, temporal, and nasal.
measure: Ocular discomfort 5-point (0-4) scale
time frame: Day 29
description: Ocular discomfort severity assessment
measure: Ocular dryness 6-point (0-5) scale
time frame: Day 29
description: Ocular dryness severity assessment
measure: Conjunctival lissamine green staining score 5-point (0-4) scale each region
time frame: Day 29
description: Dry Eye Syndrome ocular staining assessment. Conjunctival sum score: temporal and nasal.
measure: Corneal lissamine green staining score 5-point (0-4) scale each region
time frame: Day 29
description: Dry Eye Syndrome ocular staining assessment. Corneal sum score: inferior, superior and central.
measure: Worst ocular symptom 6-point (0-5) scale
time frame: Day 29
description: Most severe baseline symptom from reported daily symptoms
arm group label: TOP1630 Ophthalmic Solution
arm group type: Experimental
arm group label: Placebo to TOP1630 Ophthalmic Solution
arm group type: Placebo Comparator
intervention type: Drug
intervention name: TOP1630 0.1% Ophthalmic Solution TID OU
description: Bilateral ocular drug administration
arm group label: TOP1630 Ophthalmic Solution
intervention type: Drug
intervention name: Placebo to TOP1630 0.1% Ophthalmic Solution TID OU
description: Bilateral ocular drug administration
arm group label: Placebo to TOP1630 Ophthalmic Solution
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Syndrome
mesh term: Pharmaceutical Solutions
mesh term: Ophthalmic Solutions
sharing ipd: Undecided
submitted: February 6, 2020
returned: February 19, 2020