<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/NCT01688726</url>
  </required_header>
  <id_info>
    <org_study_id>A00977</org_study_id>
    <nct_id>NCT01688726</nct_id>
  </id_info>
  <brief_title>Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency</brief_title>
  <official_title>Evaluation of SYSTANE® BALANCE on Conjunctival Staining (CS) Visual Performance (VP) and Tear Film Kinetics (TFK) in Dry Eye Subjects With Lipid Deficiency</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 is to evaluate the repeated use of SYSTANE® BALANCE on stabilizing&#xD;
      the tear film of dry eye patients with an unstable tear film.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</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 Bulbar Conjunctival Staining</measure>
    <time_frame>Month 1</time_frame>
    <description>The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>High Contrast logMAR Time Controlled Visual Acuity (TCVA)</measure>
    <time_frame>Month 1</time_frame>
    <description>TCVA (functional visual performance) was measured with both eyes together under controlled lighting, contrast and temporal conditions using the OTG computerized vision testing system prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation with the subject's up-to-date vision correction in place. TCVA is measured in logarithm of the minimum angle of resolution (logMAR), with logMAR acuity of 0.0 considered normal distance eyesight. A negative logMAR value denotes better visual acuity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non Invasive Tear Film Break-up-time (NIBUT)</measure>
    <time_frame>Month 1</time_frame>
    <description>NIBUT was measured prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation. The time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film as observed with a specialized illumination source was recorded. A higher number represents a lengthening in the tear film break up time and greater perceived ocular comfort.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Dry Eye Syndrome</condition>
  <condition>Lipid Deficiency</condition>
  <arm_group>
    <arm_group_label>SYSTANE BALANCE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SYSTANE® BALANCE eyedrops, 1 drop 4 times a day for a continuous period of 1 month</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Minims Saline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Minims® Saline 0.9% eyedrops, 1 drop 4 times a day for a continuous period of 1 month</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SYSTANE® BALANCE eyedrops</intervention_name>
    <arm_group_label>SYSTANE BALANCE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Minims® Saline 0.9% eyedrops</intervention_name>
    <arm_group_label>Minims Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-contact lens wearer;&#xD;
&#xD;
          -  Symptomatology as defined by the Ocular Surface Disease Index (OSDI) questionnaire;&#xD;
&#xD;
          -  Lipid deficiency;&#xD;
&#xD;
          -  Best visual acuity of 6/9 or better in each eye;&#xD;
&#xD;
          -  Willingness to adhere to the instructions set in the clinical protocol;&#xD;
&#xD;
          -  Signature of the subject informed consent form;&#xD;
&#xD;
          -  Other protocol-defined inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of systemic medication which might produce dry eye side effects;&#xD;
&#xD;
          -  Systemic disease which might produce dry eye side effects;&#xD;
&#xD;
          -  Active or recent ocular inflammation or infection;&#xD;
&#xD;
          -  Use of ocular medication;&#xD;
&#xD;
          -  Significant ocular anomaly;&#xD;
&#xD;
          -  Previous ocular surgery;&#xD;
&#xD;
          -  Previous use of Restasis;&#xD;
&#xD;
          -  Any medical condition that might be prejudicial to the study;&#xD;
&#xD;
          -  Pregnant or lactating;&#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>
  <overall_official>
    <last_name>Michel Guillon, PhD, FCOptom, FAAO, CCTI</last_name>
    <role>Principal Investigator</role>
    <affiliation>OTG Research &amp; Consultancy</affiliation>
  </overall_official>
  <removed_countries>
    <country>United Kingdom</country>
  </removed_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <results_first_submitted>November 11, 2014</results_first_submitted>
  <results_first_submitted_qc>November 11, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 18, 2014</results_first_posted>
  <last_update_submitted>May 31, 2018</last_update_submitted>
  <last_update_submitted_qc>May 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dry eye</keyword>
  <keyword>Ocular surface</keyword>
  <keyword>Vision complaint</keyword>
  <keyword>Tear film stability</keyword>
  <keyword>Time controlled functional visual acuity</keyword>
  <keyword>Tear film kinetics</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ophthalmic Solutions</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from 1 clinical site located in the UK.</recruitment_details>
      <pre_assignment_details>A total of 91 participants were enrolled and randomized. This reporting group includes all randomized participants (91).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>SYSTANE BALANCE</title>
          <description>One drop 4 times a day for a continuous period of 1 month</description>
        </group>
        <group group_id="P2">
          <title>Minims Saline</title>
          <description>One drop 4 times a day for a continuous period of 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="46"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Relocated abroad</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>This analysis population includes all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>SYSTANE BALANCE</title>
          <description>One drop 4 times a day for a continuous period of 1 month</description>
        </group>
        <group group_id="B2">
          <title>Minims Saline</title>
          <description>One drop 4 times a day for a continuous period of 1 month</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="46"/>
            <count group_id="B2" value="45"/>
            <count group_id="B3" value="91"/>
          </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="46.8" spread="16.51"/>
                    <measurement group_id="B2" value="44.6" spread="14.84"/>
                    <measurement group_id="B3" value="45.7" spread="15.66"/>
                  </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="30"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Bulbar Conjunctival Staining</title>
        <description>The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome.</description>
        <time_frame>Month 1</time_frame>
        <population>This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>SYSTANE BALANCE</title>
            <description>One drop 4 times a day for a continuous period of 1 month</description>
          </group>
          <group group_id="O2">
            <title>Minims Saline</title>
            <description>One drop 4 times a day for a continuous period of 1 month</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Bulbar Conjunctival Staining</title>
          <description>The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome.</description>
          <population>This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment.</population>
          <units>percentage of staining</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Right eye</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.743" spread="1.685"/>
                    <measurement group_id="O2" value="0.442" spread="0.999"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left eye</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.531" spread="1.056"/>
                    <measurement group_id="O2" value="0.443" spread="1.404"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>High Contrast logMAR Time Controlled Visual Acuity (TCVA)</title>
        <description>TCVA (functional visual performance) was measured with both eyes together under controlled lighting, contrast and temporal conditions using the OTG computerized vision testing system prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation with the subject's up-to-date vision correction in place. TCVA is measured in logarithm of the minimum angle of resolution (logMAR), with logMAR acuity of 0.0 considered normal distance eyesight. A negative logMAR value denotes better visual acuity.</description>
        <time_frame>Month 1</time_frame>
        <population>This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>SYSTANE BALANCE</title>
            <description>One drop 4 times a day for a continuous period of 1 month</description>
          </group>
          <group group_id="O2">
            <title>Minims Saline</title>
            <description>One drop 4 times a day for a continuous period of 1 month</description>
          </group>
        </group_list>
        <measure>
          <title>High Contrast logMAR Time Controlled Visual Acuity (TCVA)</title>
          <description>TCVA (functional visual performance) was measured with both eyes together under controlled lighting, contrast and temporal conditions using the OTG computerized vision testing system prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation with the subject's up-to-date vision correction in place. TCVA is measured in logarithm of the minimum angle of resolution (logMAR), with logMAR acuity of 0.0 considered normal distance eyesight. A negative logMAR value denotes better visual acuity.</description>
          <population>This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment.</population>
          <units>logMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.220" spread="1.105"/>
                    <measurement group_id="O2" value="0.253" spread="0.100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.206" spread="1.106"/>
                    <measurement group_id="O2" value="0.295" spread="0.840"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.240" spread="1.124"/>
                    <measurement group_id="O2" value="0.202" spread="0.826"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.293" spread="1.090"/>
                    <measurement group_id="O2" value="0.206" spread="0.973"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Non Invasive Tear Film Break-up-time (NIBUT)</title>
        <description>NIBUT was measured prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation. The time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film as observed with a specialized illumination source was recorded. A higher number represents a lengthening in the tear film break up time and greater perceived ocular comfort.</description>
        <time_frame>Month 1</time_frame>
        <population>This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment. Here, n represents the number of participants with non-missing values at the specific time point for each arm group, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>SYSTANE BALANCE/Right Eye</title>
            <description>One drop 4 times a day for 1 month</description>
          </group>
          <group group_id="O2">
            <title>SYSTANE BALANCE/Left Eye</title>
            <description>One drop 4 times a day for 1 month</description>
          </group>
          <group group_id="O3">
            <title>Minims Saline/Right Eye</title>
            <description>One drop 4 times a day for 1 month</description>
          </group>
          <group group_id="O4">
            <title>Minims Saline/Left Eye</title>
            <description>One drop 4 times a day for 1 month</description>
          </group>
        </group_list>
        <measure>
          <title>Non Invasive Tear Film Break-up-time (NIBUT)</title>
          <description>NIBUT was measured prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation. The time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film as observed with a specialized illumination source was recorded. A higher number represents a lengthening in the tear film break up time and greater perceived ocular comfort.</description>
          <population>This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment. Here, n represents the number of participants with non-missing values at the specific time point for each arm group, respectively.</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="45"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=44,44)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.39" spread="7.68"/>
                    <measurement group_id="O2" value="7.47" spread="7.38"/>
                    <measurement group_id="O3" value="9.53" spread="13.19"/>
                    <measurement group_id="O4" value="7.66" spread="8.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 minutes (n=44,43)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.81" spread="10.17"/>
                    <measurement group_id="O2" value="8.74" spread="10.42"/>
                    <measurement group_id="O3" value="8.17" spread="10.45"/>
                    <measurement group_id="O4" value="6.96" spread="6.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 minutes (n=44,43)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.41" spread="9.55"/>
                    <measurement group_id="O2" value="7.59" spread="9.64"/>
                    <measurement group_id="O3" value="7.31" spread="8.33"/>
                    <measurement group_id="O4" value="6.97" spread="5.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 minutes (n=44,43)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.92" spread="6.52"/>
                    <measurement group_id="O2" value="7.26" spread="6.71"/>
                    <measurement group_id="O3" value="8.63" spread="10.08"/>
                    <measurement group_id="O4" value="6.16" spread="6.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AEs) were collected for the duration of the study (Dec2012 to Nov2013). This analysis population includes all subjects who were randomized into the study, used at least 1 eye drop, and completed at least 1 post-treatment safety assessment.</time_frame>
      <desc>An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device.</desc>
      <group_list>
        <group group_id="E1">
          <title>SYSTANE BALANCE</title>
          <description>One drop 4 times a day for a continuous period of 1 month</description>
        </group>
        <group group_id="E2">
          <title>Minims Saline</title>
          <description>One drop 4 times a day for a continuous period of 1 month</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (15.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Blood poisoning</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Knee operation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
              </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, Global Brand Medical Affairs Lead</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/NCT01688726
org study id: A00977
nct id: NCT01688726
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the repeated use of SYSTANE® BALANCE on stabilizing
      the tear film of dry eye patients with an unstable tear film.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Mean Bulbar Conjunctival Staining
time frame: Month 1
description: The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome.
measure: High Contrast logMAR Time Controlled Visual Acuity (TCVA)
time frame: Month 1
description: TCVA (functional visual performance) was measured with both eyes together under controlled lighting, contrast and temporal conditions using the OTG computerized vision testing system prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation with the subject's up-to-date vision correction in place. TCVA is measured in logarithm of the minimum angle of resolution (logMAR), with logMAR acuity of 0.0 considered normal distance eyesight. A negative logMAR value denotes better visual acuity.
measure: Non Invasive Tear Film Break-up-time (NIBUT)
time frame: Month 1
description: NIBUT was measured prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation. The time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film as observed with a specialized illumination source was recorded. A higher number represents a lengthening in the tear film break up time and greater perceived ocular comfort.
arm group label: SYSTANE BALANCE
arm group type: Experimental
description: SYSTANE® BALANCE eyedrops, 1 drop 4 times a day for a continuous period of 1 month
arm group label: Minims Saline
arm group type: Active Comparator
description: Minims® Saline 0.9% eyedrops, 1 drop 4 times a day for a continuous period of 1 month
intervention type: Other
intervention name: SYSTANE® BALANCE eyedrops
arm group label: SYSTANE BALANCE
intervention type: Other
intervention name: Minims® Saline 0.9% eyedrops
arm group label: Minims Saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michel Guillon, PhD, FCOptom, FAAO, CCTI
role: Principal Investigator
affiliation: OTG Research & Consultancy
country: United Kingdom
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Ophthalmic Solutions
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 