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/NCT06018571</url>
    </required_header>
    <id_info>
      <org_study_id>CLIF606A1US10</org_study_id>
      <nct_id>NCT06018571</nct_id>
    </id_info>
    <brief_title>Burden of Illness and Treatment Assessment of Patients With Dry Eye Disease: A Cross-Sectional Survey of Real-World Patients With Dry Eye Disease in the US</brief_title>
    <official_title>Burden of Illness and Treatment Assessment of Patients With Dry Eye Disease: A Cross-Sectional Survey of Real-World Patients With Dry Eye Disease in the US</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Novartis Pharmaceuticals</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Novartis</source>
    <brief_summary>
      <textblock>
        This study employed secondary database analysis of the Adelphi Dry Eye Disease (DED) Disease&#xD;
        Specific Programme™ (DSP™), a templatized cross-sectional survey with retrospective data&#xD;
        collection that is administered by Adelphi to a convenience sample of patients diagnosed with&#xD;
        DED, and their consulting physicians in the United States. In addition to the survey data,&#xD;
        the DED DSP also included recorded medical history data as reported by physicians&#xD;
        (optometrists, ophthalmologists or refractive surgeons).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 2, 2022</start_date>
    <completion_date type="Actual">August 19, 2022</completion_date>
    <primary_completion_date type="Actual">August 19, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Impact of Dry Eye on Everyday Life questionnaire© (IDEEL) mean scores</measure>
      <time_frame>Up to approximately 18 months</time_frame>
      <description>Mean IDEEL score on Symptom Bother dimension: score range 0-100, where higher scores indicate greater bother. Mean IDEEL scores on Daily Activities, Emotional Impact, and Work dimensions: score range 0-100, where higher scores indicate lesser impact.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Work Productivity and Activity Impairment© (WPAI) mean scores</measure>
      <time_frame>Up to approximately 18 months</time_frame>
      <description>A higher score on the WPAI indicates greater impairment and loss of productivity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Frequency of consultations</measure>
      <time_frame>Up to approximately 18 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Frequency of DED-related hospitalizations</measure>
      <time_frame>Up to approximately 18 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of emergency room (ER)/intensive care unit (ICU) admittances</measure>
      <time_frame>Up to approximately 18 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Duration of ER/ICU admittances</measure>
      <time_frame>Up to approximately 18 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of evaluations/tests administered</measure>
      <time_frame>Up to approximately 18 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Frequency of evaluations/tests administered</measure>
      <time_frame>Up to approximately 18 months</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of patients with reasons for consultation, per category</measure>
      <time_frame>Up to approximately 18 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with current (at time of data capture) treatment regimen (prescribed, over-the-counter [OTC] treatments)</measure>
      <time_frame>Up to approximately 18 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with reasons for not currently receiving any treatment for patient's DED (where appropriate), per category</measure>
      <time_frame>Up to approximately 18 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with reasons for switching away from previous treatment line (where appropriate), per category</measure>
      <time_frame>Up to approximately 18 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with &quot;other than cure their DED, the most important benefit a drug treatment could provide,&quot; per category</measure>
      <time_frame>Up to approximately 18 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Impact of Dry Eye on Everyday Life Treatment Satisfaction module© (IDEEL-TS©) mean score</measure>
      <time_frame>Up to approximately 18 months</time_frame>
      <description>Score range 0-100, where a higher score indicates greater satisfaction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of physicians assessing reasons for choice of current treatment line, per category</measure>
      <time_frame>Up to approximately 18 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of physicians assessing areas of improvement for current treatment line, per category</measure>
      <time_frame>Up to approximately 18 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients for whom cost/reimbursement was a driving factor in selection of current treatment</measure>
      <time_frame>Up to approximately 18 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients who were adherent to their current treatment plan, per category, as assessed by the physician</measure>
      <time_frame>Up to approximately 18 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients who were compliant to their current treatment plan, per category, as assessed by the physician</measure>
      <time_frame>Up to approximately 18 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of physicians assessing attributes associated with ideal medication, per category</measure>
      <time_frame>Up to approximately 18 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of physicians assessing attributes associated with currently prescribed medication, per category</measure>
      <time_frame>Up to approximately 18 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of physicians assessing influences on treatment decisions, per category</measure>
      <time_frame>Up to approximately 18 months</time_frame>
    </secondary_outcome>
    <enrollment type="Actual">946</enrollment>
    <condition>Dry Eye Disease</condition>
    <eligibility>
      <study_pop>
        <textblock>
          This was a retrospective, noninterventional cohort study&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Main Sample:&#xD;
  &#xD;
            -  ≥ 18 years of age.&#xD;
  &#xD;
            -  Physician-confirmed DED diagnosis (at time of data collection).&#xD;
  &#xD;
          Xiidra® Oversample:&#xD;
  &#xD;
            -  ≥ 18 years of age.&#xD;
  &#xD;
            -  Physician-confirmed DED diagnosis (at time of data collection).&#xD;
  &#xD;
            -  Have a current prescription for Xiidra® for their DED (at time of data collection).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Main Sample:&#xD;
  &#xD;
          • Involved in a DED clinical trial (at time of data collection).&#xD;
  &#xD;
          Xiidra® Oversample:&#xD;
  &#xD;
            -  Involved in a DED clinical trial (at time of data collection).&#xD;
  &#xD;
            -  Included in the main sample previously.&#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>Novartis Pharmaceuticals</last_name>
      <role>Study Director</role>
      <affiliation>Novartis Pharmaceuticals</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Novartis</name>
        <address>
          <city>East Hanover</city>
          <state>New Jersey</state>
          <zip>07936</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 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>
      <mesh_term>Eye Diseases</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/NCT06018571
  org study id: CLIF606A1US10
  nct id: NCT06018571
  lead sponsor: 
  This study employed secondary database analysis of the Adelphi Dry Eye Disease (DED) Disease
        Specific Programme™ (DSP™), a templatized cross-sectional survey with retrospective data
        collection that is administered by Adelphi to a convenience sample of patients diagnosed with
        DED, and their consulting physicians in the United States. In addition to the survey data,
        the DED DSP also included recorded medical history data as reported by physicians
        (optometrists, ophthalmologists or refractive surgeons).
  observational model: Cohort
  time perspective: Retrospective
  measure: Impact of Dry Eye on Everyday Life questionnaire© (IDEEL) mean scores
  time frame: Up to approximately 18 months
  description: Mean IDEEL score on Symptom Bother dimension: score range 0-100, where higher scores indicate greater bother. Mean IDEEL scores on Daily Activities, Emotional Impact, and Work dimensions: score range 0-100, where higher scores indicate lesser impact.
  measure: Work Productivity and Activity Impairment© (WPAI) mean scores
  time frame: Up to approximately 18 months
  description: A higher score on the WPAI indicates greater impairment and loss of productivity.
  measure: Frequency of consultations
  time frame: Up to approximately 18 months
  measure: Frequency of DED-related hospitalizations
  time frame: Up to approximately 18 months
  measure: Number of emergency room (ER)/intensive care unit (ICU) admittances
  time frame: Up to approximately 18 months
  measure: Duration of ER/ICU admittances
  time frame: Up to approximately 18 months
  measure: Number of evaluations/tests administered
  time frame: Up to approximately 18 months
  measure: Frequency of evaluations/tests administered
  time frame: Up to approximately 18 months
  measure: Number of patients with reasons for consultation, per category
  time frame: Up to approximately 18 months
  measure: Number of patients with current (at time of data capture) treatment regimen (prescribed, over-the-counter [OTC] treatments)
  time frame: Up to approximately 18 months
  measure: Number of patients with reasons for not currently receiving any treatment for patient's DED (where appropriate), per category
  time frame: Up to approximately 18 months
  measure: Number of patients with reasons for switching away from previous treatment line (where appropriate), per category
  time frame: Up to approximately 18 months
  measure: Number of patients with "other than cure their DED, the most important benefit a drug treatment could provide," per category
  time frame: Up to approximately 18 months
  measure: Impact of Dry Eye on Everyday Life Treatment Satisfaction module© (IDEEL-TS©) mean score
  time frame: Up to approximately 18 months
  description: Score range 0-100, where a higher score indicates greater satisfaction.
  measure: Number of physicians assessing reasons for choice of current treatment line, per category
  time frame: Up to approximately 18 months
  measure: Number of physicians assessing areas of improvement for current treatment line, per category
  time frame: Up to approximately 18 months
  measure: Number of patients for whom cost/reimbursement was a driving factor in selection of current treatment
  time frame: Up to approximately 18 months
  measure: Number of patients who were adherent to their current treatment plan, per category, as assessed by the physician
  time frame: Up to approximately 18 months
  measure: Number of patients who were compliant to their current treatment plan, per category, as assessed by the physician
  time frame: Up to approximately 18 months
  measure: Number of physicians assessing attributes associated with ideal medication, per category
  time frame: Up to approximately 18 months
  measure: Number of physicians assessing attributes associated with currently prescribed medication, per category
  time frame: Up to approximately 18 months
  measure: Number of physicians assessing influences on treatment decisions, per category
  time frame: Up to approximately 18 months
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Novartis Pharmaceuticals
  role: Study Director
  affiliation: Novartis Pharmaceuticals
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Dry Eye Syndromes
  mesh term: Keratoconjunctivitis Sicca
  mesh term: Eye Diseases