xml: <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/NCT05965778</url>
    </required_header>
    <id_info>
      <org_study_id>LT2769-002</org_study_id>
      <nct_id>NCT05965778</nct_id>
    </id_info>
    <brief_title>Comparison of the Performance and Safety of T2769 Versus Vismed® Multi in the Treatment of Moderate to Severe Dry Eye Syndrome</brief_title>
    <official_title>Comparison of the Performance and Safety of T2769 Versus Vismed® Multi in the Treatment of Moderate to Severe Dry Eye Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Laboratoires Thea</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Laboratoires Thea</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To demonstrate the non-inferiority of T2769 compared to Vismed® Multi in terms of total&#xD;
        ocular surface staining (Oxford score) after 35 days of treatment.&#xD;
  &#xD;
        To evaluate the performance and safety of T2769 versus Vismed® Multi.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <phase>N/A</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>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline (Day 1) in total ocular surface staining grade according to Oxford 0-15 grading scheme.</measure>
      <time_frame>Oxford 0-15 grading scheme: is assessed at Day 1 and Day 36</time_frame>
      <description>The primary endpoint is the change from baseline (Day 1) in total ocular surface staining grade according to Oxford 0-15 grading scheme at D36 in the study eye.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">226</enrollment>
    <condition>Dry Eye</condition>
    <arm_group>
      <arm_group_label>T2769</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Vismed® Multi</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>T2769</intervention_name>
      <description>T2769: sodium hyaluronate, Trehalose, Naaga in a 12.5 mL ABAK® multi-dose bottle.</description>
      <arm_group_label>T2769</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Vismed® Multi</intervention_name>
      <description>Hyaluronic acid</description>
      <arm_group_label>Vismed® Multi</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Informed consent signed and dated (obtained prior to initiating any procedures).&#xD;
  &#xD;
            -  Patient aged ≥18 years old.&#xD;
  &#xD;
            -  Known dry eye syndrome requiring artificial tears for at least the last 3 months prior&#xD;
               to screening visit.&#xD;
  &#xD;
            -  Surface Disease Index (OSDI) Score ≥ 23.&#xD;
  &#xD;
            -  Ocular discomfort evaluated by VAS ≥ 40 mm.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Far best-corrected visual acuity (BCVA) ≥+0.7 LogMar (e.g., ≤0.2 in decimal value or&#xD;
               ≤20/100 Snellen equivalent or ≤50 (ETDRS) letters Early Treatment Diabetic Retinopathy&#xD;
               Study).&#xD;
  &#xD;
            -  Severe blepharitis according to the judgment of the investigator&#xD;
  &#xD;
            -  Dry eye associated with at least one of the following diseases/symptoms: ocular&#xD;
               rosacea, Pterygium, Eyelid malposition, Corneal dystrophy, Ocular neoplasia,&#xD;
               Filamentous keratitis, Corneal neovascularisation, Orbital radiotherapy, Cataract,&#xD;
               Retinal disease.&#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>Frédéric CHIAMBARETTA, Prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Individual Practice for Specialized Ophthalmology Care</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Corentin LE CAMUS</last_name>
      <phone>+33473981436</phone>
      <email>Corentin.LECAMUS@theapharma.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 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 for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05965778
  org study id: LT2769-002
  nct id: NCT05965778
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To demonstrate the non-inferiority of T2769 compared to Vismed® Multi in terms of total
        ocular surface staining (Oxford score) after 35 days of treatment.
  
        To evaluate the performance and safety of T2769 versus Vismed® Multi.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Investigator)
  measure: Change from baseline (Day 1) in total ocular surface staining grade according to Oxford 0-15 grading scheme.
  time frame: Oxford 0-15 grading scheme: is assessed at Day 1 and Day 36
  description: The primary endpoint is the change from baseline (Day 1) in total ocular surface staining grade according to Oxford 0-15 grading scheme at D36 in the study eye.
  arm group label: T2769
  arm group type: Experimental
  arm group label: Vismed® Multi
  arm group type: Active Comparator
  intervention type: Device
  intervention name: T2769
  description: T2769: sodium hyaluronate, Trehalose, Naaga in a 12.5 mL ABAK® multi-dose bottle.
  arm group label: T2769
  intervention type: Device
  intervention name: Vismed® Multi
  description: Hyaluronic acid
  arm group label: Vismed® Multi
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Frédéric CHIAMBARETTA, Prof.
  role: Principal Investigator
  affiliation: Individual Practice for Specialized Ophthalmology Care
  last name: Corentin LE CAMUS
  phone: +33473981436
  email: Corentin.LECAMUS@theapharma.com
  responsible party type: Sponsor
  mesh term: Dry Eye Syndromes
  mesh term: Keratoconjunctivitis Sicca