<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/NCT01682460</url>
  </required_header>
  <id_info>
    <org_study_id>18262</org_study_id>
    <nct_id>NCT01682460</nct_id>
  </id_info>
  <brief_title>Pilot Study on the Use of Artificial Tears to Treat Dry Eye in Glaucoma Patients</brief_title>
  <acronym>IVES</acronym>
  <official_title>Pilot Study on the Use of Artificial Tears to Treat Dry Eye in Glaucoma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Waterloo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Waterloo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Research indicates that many people who are being treated for glaucoma have dry eyes. The&#xD;
      purpose of this study is to test the use of artificial tears to alleviate dryness signs and&#xD;
      symptoms in people who are using medication to treat glaucoma. The study hypothesis is that&#xD;
      the use of artificial tears will result in an improvement in clinical signs and symptoms&#xD;
      associated with dry eyes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ocular Surface Staining</measure>
    <time_frame>At baseline (dispensing visit)</time_frame>
    <description>Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= &gt;30 dots + confluence</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ocular Surface Staining</measure>
    <time_frame>After 1 week</time_frame>
    <description>Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= &gt;30 dots + confluence</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ocular Surface Staining</measure>
    <time_frame>After 1 month</time_frame>
    <description>Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= &gt;30 dots + confluence</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tear Break up Time With Fluorescein</measure>
    <time_frame>At baseline (dispensing visit)</time_frame>
    <description>The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tear Break up Time With Fluorescein</measure>
    <time_frame>After 1 week</time_frame>
    <description>The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tear Break up Time With Fluorescein</measure>
    <time_frame>After 1 month</time_frame>
    <description>The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ocular Surface Disease Index (OSDI) Score</measure>
    <time_frame>At baseline (dispensing visit)</time_frame>
    <description>The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals &quot;none of the time&quot; and 4 equals &quot;all of the time&quot;. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular Surface Disease Index (OSDI) Score</measure>
    <time_frame>1 week after using artificial tears</time_frame>
    <description>The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals &quot;none of the time&quot; and 4 equals &quot;all of the time&quot;. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular Surface Disease Index (OSDI) Score</measure>
    <time_frame>1 month after using artificial tears</time_frame>
    <description>The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals &quot;none of the time&quot; and 4 equals &quot;all of the time&quot;. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worse possible score).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Subjective Ratings of Comfort</measure>
    <time_frame>At baseline (dispensing visit)</time_frame>
    <description>Participants completed a standardized grading scale regarding their subjective ratings of comfort (0 = very poor comfort, 100=excellent comfort)</description>
  </other_outcome>
  <other_outcome>
    <measure>Subjective Ratings of Comfort</measure>
    <time_frame>1 week after using artificial tears</time_frame>
    <description>Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0= very poor comfort, 100=excellent comfort)</description>
  </other_outcome>
  <other_outcome>
    <measure>Subjective Ratings of Comfort</measure>
    <time_frame>1 month after using artificial tears</time_frame>
    <description>Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0=very poor comfort, 0 = excellent comfort)</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Glaucoma</condition>
  <condition>Dry Eyes</condition>
  <arm_group>
    <arm_group_label>Refresh Tears Lubricant Eye Drops (Allergan)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Artificial tears eye drops QID for 1 month</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Refresh Tears Lubricant Eye Drops (Allergan)</intervention_name>
    <description>Eye drops QID for 1 month</description>
    <arm_group_label>Refresh Tears Lubricant Eye Drops (Allergan)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 17 years of age and has full legal capacity to volunteer;&#xD;
&#xD;
          -  Has read and signed an information consent letter;&#xD;
&#xD;
          -  Is willing and able to follow instructions and maintain the appointment schedule;&#xD;
&#xD;
          -  Is a current non-contact lens wearer.&#xD;
&#xD;
          -  Has previously been diagnosed with primary open angle glaucoma and is currently being&#xD;
             treated with a topical therapeutic agent.&#xD;
&#xD;
          -  The glaucoma medication dosage and usage must have been the same for &gt;6 months.&#xD;
&#xD;
          -  Shows a minimum score of 2 (sometimes) on the SESOD questionnaire.&#xD;
&#xD;
          -  Distance VA of at least 20/40 in each eye with current spectacle correction.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is participating in any concurrent clinical or research study;&#xD;
&#xD;
          -  Has any known active* ocular disease and/or infection; except primary open angle&#xD;
             glaucoma.&#xD;
&#xD;
          -  Has a systemic condition that in the opinion of the investigator may affect a study&#xD;
             outcome variable;&#xD;
&#xD;
          -  Is using any systemic or topical medications (with the exception of glaucoma&#xD;
             medication) that in the opinion of the investigator may affect a study outcome&#xD;
             variable;&#xD;
&#xD;
          -  Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;&#xD;
&#xD;
          -  Is pregnant, lactating or planning a pregnancy at the time of enrolment;&#xD;
&#xD;
          -  Has undergone refractive error surgery;&#xD;
&#xD;
          -  Is an employee of the Centre for Contact Lens Research;&#xD;
&#xD;
          -  Has taken part in another (pharmaceutical) research study within the last 30 days;&#xD;
&#xD;
          -  Is currently using artificial tears more than 3 times per day.&#xD;
&#xD;
               -  For the purposes of this study, active ocular disease is defined as infection or&#xD;
                  inflammation that requires therapeutic treatment. Mild (i.e. not considered&#xD;
                  clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction,&#xD;
                  papillae), corneal and conjunctival staining and dry eye are not considered&#xD;
                  active ocular disease. Neovascularization and corneal scars are the result of&#xD;
                  previous hypoxia, infection or inflammation and are therefore not active.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lyndon Jones, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Waterloo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Contact Lens Research, University of Waterloo</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <zip>N2L 3G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <results_first_submitted>May 14, 2014</results_first_submitted>
  <results_first_submitted_qc>July 2, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 3, 2014</results_first_posted>
  <last_update_submitted>May 1, 2017</last_update_submitted>
  <last_update_submitted_qc>May 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2017</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>Glaucoma</mesh_term>
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ophthalmic Solutions</mesh_term>
    <mesh_term>Lubricant Eye Drops</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Refresh Tears Lubricant Eye Drops (Allergan)</title>
          <description>Artificial tears eye drops QID for 1 month&#xD;
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not meet inclusion criteria</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Refresh Tears Lubricant Eye Drops (Allergan)</title>
          <description>Artificial tears eye drops QID for 1 month&#xD;
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
          </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="68" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </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>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Ocular Surface Staining</title>
        <description>Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= &gt;30 dots + confluence</description>
        <time_frame>At baseline (dispensing visit)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Refresh Tears Lubricant Eye Drops (Allergan)</title>
            <description>Artificial tears eye drops QID for 1 month&#xD;
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Surface Staining</title>
          <description>Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= &gt;30 dots + confluence</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.65" spread="0.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ocular Surface Staining</title>
        <description>Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= &gt;30 dots + confluence</description>
        <time_frame>After 1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Refresh Tears Lubricant Eye Drops (Allergan)</title>
            <description>Artificial tears eye drops QID for 1 month&#xD;
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Surface Staining</title>
          <description>Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= &gt;30 dots + confluence</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.55" spread="0.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ocular Surface Staining</title>
        <description>Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= &gt;30 dots + confluence</description>
        <time_frame>After 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Refresh Tears Lubricant Eye Drops (Allergan)</title>
            <description>Artificial tears eye drops QID for 1 month&#xD;
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Surface Staining</title>
          <description>Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= &gt;30 dots + confluence</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.29" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tear Break up Time With Fluorescein</title>
        <description>The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .</description>
        <time_frame>At baseline (dispensing visit)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Refresh Tears Lubricant Eye Drops (Allergan)</title>
            <description>Artificial tears eye drops QID for 1 month&#xD;
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month</description>
          </group>
        </group_list>
        <measure>
          <title>Tear Break up Time With Fluorescein</title>
          <description>The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .</description>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.88" spread="2.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tear Break up Time With Fluorescein</title>
        <description>The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .</description>
        <time_frame>After 1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Refresh Tears Lubricant Eye Drops (Allergan)</title>
            <description>Artificial tears eye drops QID for 1 month&#xD;
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month</description>
          </group>
        </group_list>
        <measure>
          <title>Tear Break up Time With Fluorescein</title>
          <description>The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .</description>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.41" spread="2.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tear Break up Time With Fluorescein</title>
        <description>The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .</description>
        <time_frame>After 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Refresh Tears Lubricant Eye Drops (Allergan)</title>
            <description>Artificial tears eye drops QID for 1 month&#xD;
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month</description>
          </group>
        </group_list>
        <measure>
          <title>Tear Break up Time With Fluorescein</title>
          <description>The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .</description>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.01" spread="2.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ocular Surface Disease Index (OSDI) Score</title>
        <description>The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals &quot;none of the time&quot; and 4 equals &quot;all of the time&quot;. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).</description>
        <time_frame>At baseline (dispensing visit)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Refresh Tears Lubricant Eye Drops (Allergan)</title>
            <description>Artificial tears eye drops QID for 1 month&#xD;
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Surface Disease Index (OSDI) Score</title>
          <description>The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals &quot;none of the time&quot; and 4 equals &quot;all of the time&quot;. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Subjective Ratings of Comfort</title>
        <description>Participants completed a standardized grading scale regarding their subjective ratings of comfort (0 = very poor comfort, 100=excellent comfort)</description>
        <time_frame>At baseline (dispensing visit)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Refresh Tears Lubricant Eye Drops (Allergan)</title>
            <description>Artificial tears eye drops QID for 1 month&#xD;
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Ratings of Comfort</title>
          <description>Participants completed a standardized grading scale regarding their subjective ratings of comfort (0 = very poor comfort, 100=excellent comfort)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ocular Surface Disease Index (OSDI) Score</title>
        <description>The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals &quot;none of the time&quot; and 4 equals &quot;all of the time&quot;. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).</description>
        <time_frame>1 week after using artificial tears</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Refresh Tears Lubricant Eye Drops (Allergan)</title>
            <description>Artificial tears eye drops QID for 1 month&#xD;
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Surface Disease Index (OSDI) Score</title>
          <description>The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals &quot;none of the time&quot; and 4 equals &quot;all of the time&quot;. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ocular Surface Disease Index (OSDI) Score</title>
        <description>The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals &quot;none of the time&quot; and 4 equals &quot;all of the time&quot;. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worse possible score).</description>
        <time_frame>1 month after using artificial tears</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Refresh Tears Lubricant Eye Drops (Allergan)</title>
            <description>Artificial tears eye drops QID for 1 month&#xD;
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Surface Disease Index (OSDI) Score</title>
          <description>The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals &quot;none of the time&quot; and 4 equals &quot;all of the time&quot;. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worse possible score).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Subjective Ratings of Comfort</title>
        <description>Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0= very poor comfort, 100=excellent comfort)</description>
        <time_frame>1 week after using artificial tears</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Refresh Tears Lubricant Eye Drops (Allergan)</title>
            <description>Artificial tears eye drops QID for 1 month&#xD;
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Ratings of Comfort</title>
          <description>Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0= very poor comfort, 100=excellent comfort)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Subjective Ratings of Comfort</title>
        <description>Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0=very poor comfort, 0 = excellent comfort)</description>
        <time_frame>1 month after using artificial tears</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Refresh Tears Lubricant Eye Drops (Allergan)</title>
            <description>Artificial tears eye drops QID for 1 month&#xD;
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Ratings of Comfort</title>
          <description>Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0=very poor comfort, 0 = excellent comfort)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Refresh Tears Lubricant Eye Drops (Allergan)</title>
          <description>Artificial tears eye drops QID for 1 month&#xD;
Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month</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="11"/>
              </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="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Corneal marginal keratitis</sub_title>
                <description>Unrelated to study drops</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Research Manager</name_or_title>
      <organization>CCLR</organization>
      <phone>519-888-4742</phone>
      <email>cclr2@sciborg.uwaterloo.ca</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/NCT01682460
org study id: 18262
nct id: NCT01682460
lead sponsor: 
collaborator: 
has dmc: No
Research indicates that many people who are being treated for glaucoma have dry eyes. The
      purpose of this study is to test the use of artificial tears to alleviate dryness signs and
      symptoms in people who are using medication to treat glaucoma. The study hypothesis is that
      the use of artificial tears will result in an improvement in clinical signs and symptoms
      associated with dry eyes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Ocular Surface Staining
time frame: At baseline (dispensing visit)
description: Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence
measure: Ocular Surface Staining
time frame: After 1 week
description: Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence
measure: Ocular Surface Staining
time frame: After 1 month
description: Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence
measure: Tear Break up Time With Fluorescein
time frame: At baseline (dispensing visit)
description: The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .
measure: Tear Break up Time With Fluorescein
time frame: After 1 week
description: The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .
measure: Tear Break up Time With Fluorescein
time frame: After 1 month
description: The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .
measure: Ocular Surface Disease Index (OSDI) Score
time frame: At baseline (dispensing visit)
description: The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).
measure: Ocular Surface Disease Index (OSDI) Score
time frame: 1 week after using artificial tears
description: The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).
measure: Ocular Surface Disease Index (OSDI) Score
time frame: 1 month after using artificial tears
description: The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worse possible score).
measure: Subjective Ratings of Comfort
time frame: At baseline (dispensing visit)
description: Participants completed a standardized grading scale regarding their subjective ratings of comfort (0 = very poor comfort, 100=excellent comfort)
measure: Subjective Ratings of Comfort
time frame: 1 week after using artificial tears
description: Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0= very poor comfort, 100=excellent comfort)
measure: Subjective Ratings of Comfort
time frame: 1 month after using artificial tears
description: Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0=very poor comfort, 0 = excellent comfort)
arm group label: Refresh Tears Lubricant Eye Drops (Allergan)
arm group type: Experimental
description: Artificial tears eye drops QID for 1 month
intervention type: Drug
intervention name: Refresh Tears Lubricant Eye Drops (Allergan)
description: Eye drops QID for 1 month
arm group label: Refresh Tears Lubricant Eye Drops (Allergan)
criteria: 
gender: All
minimum age: 17 Years
maximum age: N/A
healthy volunteers: No
last name: Lyndon Jones, PhD
role: Principal Investigator
affiliation: University of Waterloo
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Ophthalmic Solutions
mesh term: Lubricant Eye Drops
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 