<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/NCT02252744</url>
  </required_header>
  <id_info>
    <org_study_id>WesternU-12irb027</org_study_id>
    <nct_id>NCT02252744</nct_id>
  </id_info>
  <brief_title>Prevalence of Dry Eye Disease in Patients Diagnosed With Rheumatoid Arthritis</brief_title>
  <official_title>Prevalence of Dry Eye Disease in Patients Diagnosed With Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western University of Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Western University of Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the prevalence of dry eye disease in patients diagnosed with&#xD;
      rheumatoid arthritis. No treatment is administered in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We investigated the prevalence of dry eye disease in patients diagnosed with rheumatoid&#xD;
      arthritis by information sheets and direct recruitment of patients of potential study&#xD;
      participants diagnosed with rheumatoid arthritis. Subjective assessment for dry eye disease&#xD;
      was performed using Ocular Surface Disease Index (OSDI) questionnaire. The following&#xD;
      objective tests of dry eye disease were employed: tear osmolarity (TO), tear break-up time&#xD;
      (TBUT), corneal fluorescein staining score and conjunctival lissamine green staining scores&#xD;
      using the National Eye Institute-recommended grading system, and Schirmer without anesthetic.&#xD;
      The Dry Eye Severity Grading Scheme highlighted by the Dry Eye WorkShop was adapted to&#xD;
      quantify dry eye disease severity level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Diagnosed With Rheumatoid Arthritis Also Found to Have Dry Eye Disease</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <enrollment type="Actual">286</enrollment>
  <condition>Dry Eye Syndromes</condition>
  <condition>Rheumatoid Arthritis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with diagnosis of rheumatoid arthritis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with rheumatoid arthritis&#xD;
&#xD;
          -  18 years old or older&#xD;
&#xD;
          -  Speaks and understands English and/or Spanish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide consent&#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>Jasmine W Yumori, OD FAAO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western University of Health Sciences</affiliation>
  </overall_official>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <results_first_submitted>September 22, 2015</results_first_submitted>
  <results_first_submitted_qc>February 2, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 3, 2016</results_first_posted>
  <last_update_submitted>February 2, 2016</last_update_submitted>
  <last_update_submitted_qc>February 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western University of Health Sciences</investigator_affiliation>
    <investigator_full_name>Jasmine Yumori</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>dry eye disease</keyword>
  <keyword>rheumatoid arthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
    <mesh_term>Eye Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>RA Patients</title>
          <description>Adult patients diagnosed with rheumatoid arthritis</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="286"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="286"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>RA Patients</title>
          <description>Adult patients diagnosed with rheumatoid arthritis</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="286"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.46821" spread="13.46821"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <description>Gender data unavailable for 2 participants</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="243"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="141"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="141"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="216"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="286"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Diagnosed With Rheumatoid Arthritis Also Found to Have Dry Eye Disease</title>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RA Patients</title>
            <description>Adult patients diagnosed with rheumatoid arthritis</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Diagnosed With Rheumatoid Arthritis Also Found to Have Dry Eye Disease</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="286"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="275"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>RA Patients</title>
          <description>Adult patients diagnosed with rheumatoid arthritis</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="286"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jasmine Wong Yumori OD FAAO</name_or_title>
      <organization>Western University of Health Sciences</organization>
      <phone>(909) 706-3886</phone>
      <email>jyumori@westernu.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02252744
org study id: WesternU-12irb027
nct id: NCT02252744
lead sponsor: 
collaborator: 
has dmc: No
This study will evaluate the prevalence of dry eye disease in patients diagnosed with
      rheumatoid arthritis. No treatment is administered in this study.
We investigated the prevalence of dry eye disease in patients diagnosed with rheumatoid
      arthritis by information sheets and direct recruitment of patients of potential study
      participants diagnosed with rheumatoid arthritis. Subjective assessment for dry eye disease
      was performed using Ocular Surface Disease Index (OSDI) questionnaire. The following
      objective tests of dry eye disease were employed: tear osmolarity (TO), tear break-up time
      (TBUT), corneal fluorescein staining score and conjunctival lissamine green staining scores
      using the National Eye Institute-recommended grading system, and Schirmer without anesthetic.
      The Dry Eye Severity Grading Scheme highlighted by the Dry Eye WorkShop was adapted to
      quantify dry eye disease severity level.
observational model: Case-Only
time perspective: Prospective
measure: Number of Participants Diagnosed With Rheumatoid Arthritis Also Found to Have Dry Eye Disease
time frame: 1 day
intervention type: Other
intervention name: No intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jasmine W Yumori, OD FAAO
role: Principal Investigator
affiliation: Western University of Health Sciences
responsible party type: Principal Investigator
investigator affiliation: Western University of Health Sciences
investigator full name: Jasmine Yumori
investigator title: Associate Professor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Eye Diseases
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 