<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/NCT01733745</url>
  </required_header>
  <id_info>
    <org_study_id>A00978</org_study_id>
    <nct_id>NCT01733745</nct_id>
  </id_info>
  <brief_title>SYSTANE® Family - Meibomian Deficiency</brief_title>
  <acronym>M-12-077</acronym>
  <official_title>SYSTANE® Family Efficacy in Meibomian Gland Functionality for Lipid Deficient Evaporative Dry Eye Subjects</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 assess the efficacy of the SYSTANE® family of products&#xD;
      (SYSTANE® Lid Wipes, SYSTANE® BALANCE Lubricant Eye Drops, and SYSTANE® Vitamins) on&#xD;
      meibomian gland functionality in subjects with lipid deficiency related to evaporative dry&#xD;
      eye as compared to the standard of care warm compresses.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 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>Number of Meibomian Glands Yielding Liquid Secretion (MGLYS)</measure>
    <time_frame>Baseline, Month 1, Month 2, Month 3</time_frame>
    <description>Meibomian gland functionality was evaluated by the investigator using the Meibomian Gland Evaluator (MGE), a handheld instrument that provides a standardized method for applying consistent, gentle pressure to the outer skin of the lower eyelid. The total number of meibomian gland orificies evidencing liquid secretion during expression with the MGE, in both eyes, was recorded. A lower number of functioning meibomian glands may contribute to dry eye syndrome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses</measure>
    <time_frame>Baseline, Month 1, Month 2, Month 3</time_frame>
    <description>The Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire is a 16-question validated questionnaire (resultant overall score 0-28, with 0 being best and 28 being worst) that measures the frequency and severity of dry eye symptoms. The SPEED questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses</measure>
    <time_frame>Baseline, Month 1, Month 2, Month 3</time_frame>
    <description>The Dry Eye OSDI Questionnaire is a 12-question validated questionnaire [resultant overall 0-100 score, with 0 being none of the time (best) and 100 being all of the time (worst)] that measures ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Dry Eye Syndrome</condition>
  <arm_group>
    <arm_group_label>SYSTANE® Family</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Microfiber towels (as warm compresses, with or without saline eye drops) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SYSTANE® Lid Wipes</intervention_name>
    <description>Pre-moistened eyelid cleansing wipes for topical ocular external scrubbing of eyelids and eyelashes</description>
    <arm_group_label>SYSTANE® Family</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SYSTANE® BALANCE</intervention_name>
    <description>Lubricant Eye Drops</description>
    <arm_group_label>SYSTANE® Family</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>SYSTANE® Vitamins</intervention_name>
    <arm_group_label>SYSTANE® Family</arm_group_label>
    <other_name>SYSTANE® Vitamin Omega-3 Supplement</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Microfiber towels (as warm compresses, with or without saline eye drops)</intervention_name>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must have a clinical diagnosis of lipid deficient Evaporative Dry Eye;&#xD;
&#xD;
          -  Meibomian Gland Functionality - Not more than 6 glands yielding liquid secretion;&#xD;
&#xD;
          -  Must be willing to discontinue the use of all other Meibomian Gland; Dysfunction&#xD;
             management prior to receiving the study test article at Visit 1, up until the end of&#xD;
             the study period;&#xD;
&#xD;
          -  Must have best corrected visual acuity of 20/40 Snellen or better in each eye;&#xD;
&#xD;
          -  Must be able to follow instructions and be willing and able to attend required study&#xD;
             visits;&#xD;
&#xD;
          -  Must read, sign, and date an Ethics Committee reviewed and approved informed consent&#xD;
             form;&#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 6 months;&#xD;
&#xD;
          -  Current punctal occlusion of any type (e.g., collagen plugs, silicone 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;
          -  Pregnant or lactating at the time of enrollment;&#xD;
&#xD;
          -  Not willing to take adequate precautions not to become pregnant during the study;&#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 that may preclude the safe administration of either drop under&#xD;
             investigation;&#xD;
&#xD;
          -  Unwilling to discontinue contact lens wear during the study period and for at least 1&#xD;
             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>
  <overall_official>
    <last_name>Danyel C. Carr, MS, CCRA</last_name>
    <role>Study Director</role>
    <affiliation>Alcon Research</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Donald R Korb, O.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korb and Associates</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <results_first_submitted>June 2, 2014</results_first_submitted>
  <results_first_submitted_qc>June 2, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 3, 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>lipid deficiency</keyword>
  <keyword>meibomian gland</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>Vitamins</mesh_term>
    <mesh_term>Ophthalmic Solutions</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from 1 study center located in the US.</recruitment_details>
      <pre_assignment_details>This reporting group includes all subjects who were enrolled and received at least one of the study treatments (26).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>SYSTANE® Family</title>
          <description>SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care</title>
          <description>Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="13"/>
              </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>
      <population>This reporting group includes all subjects who were enrolled and received at least one of the study treatments.</population>
      <group_list>
        <group group_id="B1">
          <title>SYSTANE® Family</title>
          <description>SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.</description>
        </group>
        <group group_id="B2">
          <title>Standard of Care</title>
          <description>Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.</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="13"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="26"/>
          </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="38.1" spread="19.9"/>
                    <measurement group_id="B2" value="45.4" spread="19.8"/>
                    <measurement group_id="B3" value="41.7" spread="19.8"/>
                  </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="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Meibomian Glands Yielding Liquid Secretion (MGLYS)</title>
        <description>Meibomian gland functionality was evaluated by the investigator using the Meibomian Gland Evaluator (MGE), a handheld instrument that provides a standardized method for applying consistent, gentle pressure to the outer skin of the lower eyelid. The total number of meibomian gland orificies evidencing liquid secretion during expression with the MGE, in both eyes, was recorded. A lower number of functioning meibomian glands may contribute to dry eye syndrome.</description>
        <time_frame>Baseline, Month 1, Month 2, Month 3</time_frame>
        <population>This reporting group includes all subjects who were enrolled and received at least one of the study treatments.</population>
        <group_list>
          <group group_id="O1">
            <title>SYSTANE® Family</title>
            <description>SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Meibomian Glands Yielding Liquid Secretion (MGLYS)</title>
          <description>Meibomian gland functionality was evaluated by the investigator using the Meibomian Gland Evaluator (MGE), a handheld instrument that provides a standardized method for applying consistent, gentle pressure to the outer skin of the lower eyelid. The total number of meibomian gland orificies evidencing liquid secretion during expression with the MGE, in both eyes, was recorded. A lower number of functioning meibomian glands may contribute to dry eye syndrome.</description>
          <population>This reporting group includes all subjects who were enrolled and received at least one of the study treatments.</population>
          <units>functioning glands</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="1.50"/>
                    <measurement group_id="O2" value="4.2" spread="1.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" spread="3.12"/>
                    <measurement group_id="O2" value="3.9" spread="1.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4" spread="2.45"/>
                    <measurement group_id="O2" value="3.5" spread="1.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.3" spread="2.72"/>
                    <measurement group_id="O2" value="4.7" spread="2.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses</title>
        <description>The Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire is a 16-question validated questionnaire (resultant overall score 0-28, with 0 being best and 28 being worst) that measures the frequency and severity of dry eye symptoms. The SPEED questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.</description>
        <time_frame>Baseline, Month 1, Month 2, Month 3</time_frame>
        <population>This reporting group includes all subjects who were enrolled and received at least one of the study treatments.</population>
        <group_list>
          <group group_id="O1">
            <title>SYSTANE® Family</title>
            <description>SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses</title>
          <description>The Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire is a 16-question validated questionnaire (resultant overall score 0-28, with 0 being best and 28 being worst) that measures the frequency and severity of dry eye symptoms. The SPEED questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.</description>
          <population>This reporting group includes all subjects who were enrolled and received at least one of the study treatments.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.2" spread="2.59"/>
                    <measurement group_id="O2" value="11.2" spread="1.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2" spread="3.24"/>
                    <measurement group_id="O2" value="9.5" spread="3.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" spread="3.02"/>
                    <measurement group_id="O2" value="7.9" spread="4.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" spread="3.42"/>
                    <measurement group_id="O2" value="7.9" spread="4.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses</title>
        <description>The Dry Eye OSDI Questionnaire is a 12-question validated questionnaire [resultant overall 0-100 score, with 0 being none of the time (best) and 100 being all of the time (worst)] that measures ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.</description>
        <time_frame>Baseline, Month 1, Month 2, Month 3</time_frame>
        <population>This reporting group includes all subjects who were enrolled and received at least one of the study treatments.</population>
        <group_list>
          <group group_id="O1">
            <title>SYSTANE® Family</title>
            <description>SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses</title>
          <description>The Dry Eye OSDI Questionnaire is a 12-question validated questionnaire [resultant overall 0-100 score, with 0 being none of the time (best) and 100 being all of the time (worst)] that measures ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.</description>
          <population>This reporting group includes all subjects who were enrolled and received at least one of the study treatments.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.3" spread="12.82"/>
                    <measurement group_id="O2" value="26.9" spread="15.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.6" spread="10.48"/>
                    <measurement group_id="O2" value="21.0" spread="16.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.1" spread="9.57"/>
                    <measurement group_id="O2" value="19.7" spread="17.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.4" spread="10.20"/>
                    <measurement group_id="O2" value="17.9" spread="18.55"/>
                  </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 (4 months). This analysis group includes all enrolled and exposed subjects.</time_frame>
      <desc>An AE is defined as any untoward medical occurrence in a subject who is administered a study treatment (i.e., initiation of treatment with test article) regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments by the participant.</desc>
      <group_list>
        <group group_id="E1">
          <title>SYSTANE® Family</title>
          <description>SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care</title>
          <description>Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.</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="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infectious mononucleosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </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, 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/NCT01733745
org study id: A00978
nct id: NCT01733745
lead sponsor: 
has dmc: No
The purpose of this study was to assess the efficacy of the SYSTANE® family of products
      (SYSTANE® Lid Wipes, SYSTANE® BALANCE Lubricant Eye Drops, and SYSTANE® Vitamins) on
      meibomian gland functionality in subjects with lipid deficiency related to evaporative dry
      eye as compared to the standard of care warm compresses.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Number of Meibomian Glands Yielding Liquid Secretion (MGLYS)
time frame: Baseline, Month 1, Month 2, Month 3
description: Meibomian gland functionality was evaluated by the investigator using the Meibomian Gland Evaluator (MGE), a handheld instrument that provides a standardized method for applying consistent, gentle pressure to the outer skin of the lower eyelid. The total number of meibomian gland orificies evidencing liquid secretion during expression with the MGE, in both eyes, was recorded. A lower number of functioning meibomian glands may contribute to dry eye syndrome.
measure: Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses
time frame: Baseline, Month 1, Month 2, Month 3
description: The Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire is a 16-question validated questionnaire (resultant overall score 0-28, with 0 being best and 28 being worst) that measures the frequency and severity of dry eye symptoms. The SPEED questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.
measure: Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses
time frame: Baseline, Month 1, Month 2, Month 3
description: The Dry Eye OSDI Questionnaire is a 12-question validated questionnaire [resultant overall 0-100 score, with 0 being none of the time (best) and 100 being all of the time (worst)] that measures ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.
arm group label: SYSTANE® Family
arm group type: Experimental
description: SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
arm group label: Standard of Care
arm group type: Active Comparator
description: Microfiber towels (as warm compresses, with or without saline eye drops) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
intervention type: Other
intervention name: SYSTANE® Lid Wipes
description: Pre-moistened eyelid cleansing wipes for topical ocular external scrubbing of eyelids and eyelashes
arm group label: SYSTANE® Family
intervention type: Other
intervention name: SYSTANE® BALANCE
description: Lubricant Eye Drops
arm group label: SYSTANE® Family
intervention type: Dietary Supplement
intervention name: SYSTANE® Vitamins
arm group label: SYSTANE® Family
other name: SYSTANE® Vitamin Omega-3 Supplement
intervention type: Other
intervention name: Microfiber towels (as warm compresses, with or without saline eye drops)
arm group label: Standard of Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Danyel C. Carr, MS, CCRA
role: Study Director
affiliation: Alcon Research
last name: Donald R Korb, O.D.
role: Principal Investigator
affiliation: Korb and Associates
country: United States
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Vitamins
mesh term: Ophthalmic Solutions
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 