<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/NCT01718028</url>
  </required_header>
  <id_info>
    <org_study_id>RDG-11-262</org_study_id>
    <nct_id>NCT01718028</nct_id>
  </id_info>
  <brief_title>The Effect of SYSTANE® BALANCE on Tear Film Break Up Time in Dry Eye Subjects</brief_title>
  <official_title>The Effect of SYSTANE® BALANCE on Non-Invasive Tear Film Break Up Time (NITFBUT) in Dry Eye Subjects With Lipid Deficiency Following 30 Days of Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alcon Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alcon Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to evaluate the ability of SYSTANE® BALANCE dosed 4 times a day&#xD;
      for 30 days to increase non-invasive tear film break up time over baseline, compared to a&#xD;
      saline control, in dry eye subjects with lipid deficiency.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</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>Mean Change From Baseline in NITFBUT at Day 30</measure>
    <time_frame>Baseline (Day 0), Day 30</time_frame>
    <description>NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in NITFBUT at Day 14</measure>
    <time_frame>Baseline (Day 0), Day 14</time_frame>
    <description>NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean NITFBUT by Visit</measure>
    <time_frame>Baseline (Day 0), Day 14, Day 30</time_frame>
    <description>NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A longer tear film break-up time indicates a more stable tear film, which may improve dry eye symptoms in dry eye sufferers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in NITFBUT by Visit</measure>
    <time_frame>Baseline (Day 0), Day 14, Day 30</time_frame>
    <description>NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. The percentage of participants with a lengthening in tear film break up time relative to baseline is reported. A positive value indicates an improvement in film stability, which may improve dry eye symptoms in dry eye sufferers.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Dry Eye</condition>
  <arm_group>
    <arm_group_label>SYSTANE® BALANCE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LARMABAK®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Propylene glycol 0.6% ocular emulsion</intervention_name>
    <arm_group_label>SYSTANE® BALANCE</arm_group_label>
    <other_name>SYSTANE® BALANCE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sodium chloride 0.9% saline solution</intervention_name>
    <arm_group_label>LARMABAK®</arm_group_label>
    <other_name>LARMABAK®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Read, sign, and date an information consent;&#xD;
&#xD;
          -  Willing and able to follow instructions and maintain the appointment schedule;&#xD;
&#xD;
          -  Best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed at Visit&#xD;
             1;&#xD;
&#xD;
          -  Must not have used any topical ocular drops for approximately 24 hours prior to Visit&#xD;
             1;&#xD;
&#xD;
          -  Meet protocol-specified criteria for dry eye at Visit 1;&#xD;
&#xD;
          -  Other protocol-defined inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or evidence of ocular or intraocular surgery or serious ocular trauma in&#xD;
             either eye within the past six months;&#xD;
&#xD;
          -  Current punctal occlusion of any type (e.g., collagen plugs, silicon plugs);&#xD;
&#xD;
          -  History of intolerance or hypersensitivity to any component of the study medications;&#xD;
&#xD;
          -  History or evidence of epithelial herpes simplex keratitis (dendritic keratitis);&#xD;
             vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva;&#xD;
             chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids;&#xD;
             mycobacterial infection of the eye; and/or fungal disease of the eye;&#xD;
&#xD;
          -  Use of any concomitant topical ocular medications during the study period;&#xD;
&#xD;
          -  Use of systemic medications that may contribute to dry eye unless on a stable dosing&#xD;
             regimen for a minimum of 30 days prior to Visit 1;&#xD;
&#xD;
          -  Ocular conditions such as conjunctival infections, iritis, or any other ocular&#xD;
             condition that may preclude the safe administration of either drop under&#xD;
             investigation;&#xD;
&#xD;
          -  Unwilling to discontinue contact lens wear during the study period. Contact lens wear&#xD;
             must have been discontinued at least one week prior to Visit 1.&#xD;
&#xD;
          -  Participation in an investigational drug or device study within 30 days of entering&#xD;
             this study;&#xD;
&#xD;
          -  Other protocol-defined exclusion criteria may apply.&#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>Consultório Oftalmológico</name>
      <address>
        <city>Martinez</city>
        <state>Buenos Aires</state>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <results_first_submitted>November 15, 2013</results_first_submitted>
  <results_first_submitted_qc>November 15, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 6, 2014</results_first_posted>
  <last_update_submitted>November 15, 2013</last_update_submitted>
  <last_update_submitted_qc>November 15, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Systane BALANCE</keyword>
  <keyword>Dry eye</keyword>
  <keyword>lipid deficiency</keyword>
  <keyword>NITFBUT</keyword>
  <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>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from 1 study center located in Argentina.</recruitment_details>
      <pre_assignment_details>Of the 51 enrolled, 2 participants withdrew their consent prior to receiving treatment and were exited from the study. This reporting group includes all participants who received treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>SYSTANE® BALANCE</title>
          <description>Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days</description>
        </group>
        <group group_id="P2">
          <title>LARMABAK®</title>
          <description>Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>SYSTANE® BALANCE</title>
          <description>Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days</description>
        </group>
        <group group_id="B2">
          <title>LARMABAK®</title>
          <description>Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
            <count group_id="B2" value="24"/>
            <count group_id="B3" value="49"/>
          </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="45.52" spread="20.06"/>
                    <measurement group_id="B2" value="42.96" spread="17.71"/>
                    <measurement group_id="B3" value="44.27" spread="18.79"/>
                  </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="18"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </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>Argentina</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline in NITFBUT at Day 30</title>
        <description>NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.</description>
        <time_frame>Baseline (Day 0), Day 30</time_frame>
        <population>Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit</population>
        <group_list>
          <group group_id="O1">
            <title>SYSTANE® BALANCE</title>
            <description>Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days</description>
          </group>
          <group group_id="O2">
            <title>LARMABAK®</title>
            <description>Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in NITFBUT at Day 30</title>
          <description>NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.</description>
          <population>Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit</population>
          <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="25"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.83" spread="0.74"/>
                    <measurement group_id="O2" value="0.66" spread="0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in NITFBUT at Day 14</title>
        <description>NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.</description>
        <time_frame>Baseline (Day 0), Day 14</time_frame>
        <population>Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit</population>
        <group_list>
          <group group_id="O1">
            <title>SYSTANE® BALANCE</title>
            <description>Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days</description>
          </group>
          <group group_id="O2">
            <title>LARMABAK®</title>
            <description>Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in NITFBUT at Day 14</title>
          <description>NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.</description>
          <population>Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit</population>
          <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="25"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.98" spread="0.60"/>
                    <measurement group_id="O2" value="0.65" spread="0.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean NITFBUT by Visit</title>
        <description>NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A longer tear film break-up time indicates a more stable tear film, which may improve dry eye symptoms in dry eye sufferers.</description>
        <time_frame>Baseline (Day 0), Day 14, Day 30</time_frame>
        <population>Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit</population>
        <group_list>
          <group group_id="O1">
            <title>SYSTANE® BALANCE</title>
            <description>Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days</description>
          </group>
          <group group_id="O2">
            <title>LARMABAK®</title>
            <description>Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days</description>
          </group>
        </group_list>
        <measure>
          <title>Mean NITFBUT by Visit</title>
          <description>NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A longer tear film break-up time indicates a more stable tear film, which may improve dry eye symptoms in dry eye sufferers.</description>
          <population>Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit</population>
          <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="25"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.60" spread="0.69"/>
                    <measurement group_id="O2" value="4.93" spread="0.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.58" spread="0.74"/>
                    <measurement group_id="O2" value="5.57" spread="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.43" spread="0.51"/>
                    <measurement group_id="O2" value="5.59" spread="0.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in NITFBUT by Visit</title>
        <description>NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. The percentage of participants with a lengthening in tear film break up time relative to baseline is reported. A positive value indicates an improvement in film stability, which may improve dry eye symptoms in dry eye sufferers.</description>
        <time_frame>Baseline (Day 0), Day 14, Day 30</time_frame>
        <population>Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit</population>
        <group_list>
          <group group_id="O1">
            <title>SYSTANE® BALANCE</title>
            <description>Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days</description>
          </group>
          <group group_id="O2">
            <title>LARMABAK®</title>
            <description>Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in NITFBUT by Visit</title>
          <description>NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. The percentage of participants with a lengthening in tear film break up time relative to baseline is reported. A positive value indicates an improvement in film stability, which may improve dry eye symptoms in dry eye sufferers.</description>
          <population>Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percent Change from Baseline at Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.99" spread="19.46"/>
                    <measurement group_id="O2" value="14.35" spread="17.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent Change from Baseline at Day 30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.03" spread="28.41"/>
                    <measurement group_id="O2" value="15.06" spread="14.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected for the duration of the study (1 month, 3 days). An adverse event was defined as any untoward medical occurrence in a subject administered the test product, regardless of causal relationship.</time_frame>
      <desc>This reporting group includes all participants who received at least one dose of Systane® BALANCE or saline solution.</desc>
      <group_list>
        <group group_id="E1">
          <title>SYSTANE® BALANCE</title>
          <description>Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days</description>
        </group>
        <group group_id="E2">
          <title>LARMABAK®</title>
          <description>Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days</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="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </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="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </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>Sponsor reserves the right of prior review of any publication or presentation of information related to the study.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Abayomi Ogundele, Pharm.D.</name_or_title>
      <organization>Alcon Research, Ltd.</organization>
      <phone>1-888-451-3937</phone>
      <email>alcon.medinfo@alcon.com</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/NCT01718028
org study id: RDG-11-262
nct id: NCT01718028
lead sponsor: 
has dmc: No
The purpose of this study was to evaluate the ability of SYSTANE® BALANCE dosed 4 times a day
      for 30 days to increase non-invasive tear film break up time over baseline, compared to a
      saline control, in dry eye subjects with lipid deficiency.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Mean Change From Baseline in NITFBUT at Day 30
time frame: Baseline (Day 0), Day 30
description: NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.
measure: Mean Change From Baseline in NITFBUT at Day 14
time frame: Baseline (Day 0), Day 14
description: NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.
measure: Mean NITFBUT by Visit
time frame: Baseline (Day 0), Day 14, Day 30
description: NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A longer tear film break-up time indicates a more stable tear film, which may improve dry eye symptoms in dry eye sufferers.
measure: Percent Change From Baseline in NITFBUT by Visit
time frame: Baseline (Day 0), Day 14, Day 30
description: NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. The percentage of participants with a lengthening in tear film break up time relative to baseline is reported. A positive value indicates an improvement in film stability, which may improve dry eye symptoms in dry eye sufferers.
arm group label: SYSTANE® BALANCE
arm group type: Experimental
description: Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
arm group label: LARMABAK®
arm group type: Active Comparator
description: Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
intervention type: Other
intervention name: Propylene glycol 0.6% ocular emulsion
arm group label: SYSTANE® BALANCE
other name: SYSTANE® BALANCE
intervention type: Other
intervention name: Sodium chloride 0.9% saline solution
arm group label: LARMABAK®
other name: LARMABAK®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Argentina
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 