<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/NCT03253393</url>
  </required_header>
  <id_info>
    <org_study_id>SOVS2017-050</org_study_id>
    <nct_id>NCT03253393</nct_id>
  </id_info>
  <brief_title>Smart Touch Non-dispensing Handling Studies</brief_title>
  <official_title>Microbial Contamination Rates on the Back Surface of Soft Contact Lenses in Two Short-term, Randomized, Contralateral Non-dispensing Studies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of New South Wales</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Menicon Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of New South Wales</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a randomized, contralateral, investigator-masked non-dispensing study, to&#xD;
      investigate the microbial contamination rates on the back surface of two types of soft&#xD;
      contact lenses (hydrogel and silicone hydrogel) extracted from Smart Touch Technology blister&#xD;
      packs versus conventional lens packaging after short-term placement on the eye, and to&#xD;
      compare the microbial contamination rates of the worn contact lenses to those on the&#xD;
      participants' hands/fingers used to conduct lens insertion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a prospective, single centre, randomized, contralateral, investigator-masked&#xD;
      non-dispensing study. This study requires three visits of approx. 1 hour duration each.&#xD;
&#xD;
      At the first visit, the order in which the hydrogel (no EDTA) and silicone hydrogel (with&#xD;
      EDTA) contact lenses are allocated to the study participants will be randomized. At the&#xD;
      second visit, participants will be crossed over to the alternate lens type (hydrogel no EDTA&#xD;
      or silicone hydrogel with EDTA).&#xD;
&#xD;
      At the third visit, participants will be randomly allocated to wear the hydrogel lens (with&#xD;
      EDTA) in one eye and the silicone hydrogel lens (no EDTA) in the other eye, both removed from&#xD;
      Smart Touch Technology packaging.&#xD;
&#xD;
      At each visit, participants will be instructed to:&#xD;
&#xD;
        -  Wash their hands prior to handling the contact lenses;&#xD;
&#xD;
        -  Swab their thumb and two index fingers of the hand routinely used to conduct contact&#xD;
           lens insertion using a sterile cotton swab moistened with sterile preservative free&#xD;
           saline for the evaluation of skin microbiota;&#xD;
&#xD;
        -  Follow the manufacturer's guidelines for lens insertion;&#xD;
&#xD;
        -  Open the blister pack and insert the contact lens randomly assigned for the right eye;&#xD;
&#xD;
        -  Open the blister pack and insert the contact lens assigned for the left eye;&#xD;
&#xD;
        -  Contact lenses will be removed aseptically by a masked investigator after 45 minutes of&#xD;
           lens wear.&#xD;
&#xD;
      Lenses and finger swabs will be analysed for microbial contamination using established&#xD;
      routine microbiology protocols. The number and species of organisms will be determined.&#xD;
&#xD;
      A minimum washout period of 48 hours will occur between the study visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 4, 2018</start_date>
  <completion_date type="Actual">February 27, 2019</completion_date>
  <primary_completion_date type="Actual">February 27, 2019</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Contralateral study</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Without Contamination of Contact Lenses</measure>
    <time_frame>After 45 minutes of lens wear</time_frame>
    <description>Number of Participants Without Contamination of Contact Lenses after 45 minutes of wear</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bacterial Counts of Worn Contact Lenses</measure>
    <time_frame>After 45 minutes of lens wear</time_frame>
    <description>Bacterial counts of contact lenses after 45 minutes of wear (CFU count /lens)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Optometry</condition>
  <arm_group>
    <arm_group_label>Silicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Silicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hydrogel (no EDTA) in Smart Touch vs. in conventional packaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hydrogel (no EDTA) in Smart Touch vs. in conventional packaging</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Silicone hydrogel (no EDTA) vs. hydrogel (with EDTA) in Smart Touch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Silicone hydrogel (no EDTA) vs. hydrogel (with EDTA) in Smart Touch</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Smart Touch Technology packaging</intervention_name>
    <description>hioxifilcon A contact lens in Smart Touch Technology (hydrogel, no EDTA) midafilcon A contact lens in Smart Touch Technology (silicone hydrogel, with EDTA)</description>
    <arm_group_label>Hydrogel (no EDTA) in Smart Touch vs. in conventional packaging</arm_group_label>
    <arm_group_label>Silicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional lens packaging</intervention_name>
    <description>hioxifilcon A contact lens in conventional lens packaging (hydrogel, no EDTA) midafilcon A contact lens in conventional lens packaging (silicone hydrogel, with EDTA)</description>
    <arm_group_label>Hydrogel (no EDTA) in Smart Touch vs. in conventional packaging</arm_group_label>
    <arm_group_label>Silicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EDTA</intervention_name>
    <description>hioxifilcon A contact lens in Smart Touch Technology (hydrogel, with EDTA) midafilcon A contact lens in Smart Touch Technology (silicone hydrogel, no EDTA)</description>
    <arm_group_label>Silicone hydrogel (no EDTA) vs. hydrogel (with EDTA) in Smart Touch</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to read and comprehend English and give informed consent as demonstrated by&#xD;
             signing a Participant Information Statement and Consent Form;&#xD;
&#xD;
          -  Be at least 18 years old;&#xD;
&#xD;
          -  Experienced soft contact lens wearer;&#xD;
&#xD;
          -  Willing to refrain from wearing contact lenses for 24 hours prior to the scheduled&#xD;
             study visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years old;&#xD;
&#xD;
          -  Have any active corneal infection, ocular disease or systemic disease that would&#xD;
             affect wearing of contact lenses;&#xD;
&#xD;
          -  Use or have a need for any systemic or topical medications which may alter normal&#xD;
             ocular findings/are known to affect a participant's ocular health/physiology either in&#xD;
             an adverse manner or risk providing a false positive;&#xD;
&#xD;
          -  Have had eye surgery within 12 weeks immediately prior to enrolment for this trial;&#xD;
&#xD;
          -  Have contraindications to contact lens wear;&#xD;
&#xD;
          -  Have a greater than 2 line reduction in habitual visual acuity while wearing the study&#xD;
             contact lenses;&#xD;
&#xD;
          -  Be currently enrolled in another clinical trial;&#xD;
&#xD;
          -  Be pregnant (verbal self-report)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>School of Optometry and Vision Science</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2052</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <results_first_submitted>May 25, 2021</results_first_submitted>
  <results_first_submitted_qc>October 10, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 2, 2021</results_first_posted>
  <last_update_submitted>November 3, 2021</last_update_submitted>
  <last_update_submitted_qc>November 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of New South Wales</investigator_affiliation>
    <investigator_full_name>Jacqueline Tan-Showyin</investigator_full_name>
    <investigator_title>Senior Research Fellow</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/93/NCT03253393/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>25 subjects were required to complete each of the three study interventions</recruitment_details>
      <pre_assignment_details>25 subjects were enrolled and randomised. Of those randomised, 13 did not complete the third visit/intervention. Therefore an additional 13 subjects were recruited to complete the third intervention only.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>SiH (With EDTA) , Then H (no EDTA), Then SiH (Without EDTA) and H (With EDTA) in Smart Touch</title>
          <description>Participants first received a Silicone Hydrogel lens (with EDTA) in Smart Touch packaging which was inserted in one eye and a Silicone Hydrogel lens (with EDTA) in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours, they then received a Hydrogel lens (no EDTA) in Smart Touch packaging which was inserted in one eye and a Hydrogel lens in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours they then received a Silicone Hydrogel lens (without EDTA) in Smart Touch packaging in one eye and a Hydrogel lens (with EDTA) in Smart Touch packaging in the other eye.&#xD;
Smart Touch Technology packaging: midafilcon A contact lens in Smart Touch Technology Flat Pack (silicone hydrogel, with EDTA)&#xD;
Conventional lens packaging: hioxifilcon A contact lens in conventional lens packaging (hydrogel, no EDTA) asmofilcon A contact lens in conventional lens packaging (silicone hydrogel, with EDTA)</description>
        </group>
        <group group_id="P2">
          <title>H (no EDTA), Then SiH (With EDTA), Then SiH (Without EDTA) vs H (With EDTA) in Smart Touch</title>
          <description>Participants first received a Hydrogel lens (no EDTA) in Smart Touch packaging which was inserted in one eye and a Hydrogel lens in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours, they then received a Silicone Hydrogel lens (with EDTA) in Smart Touch packaging which was inserted in one eye and a Silicone Hydrogel lens (with EDTA) in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours they then received a Silicone Hydrogel lens (without EDTA) in Smart Touch packaging in one eye and a Hydrogel lens (with EDTA) in Smart Touch packaging in the other eye.</description>
        </group>
        <group group_id="P3">
          <title>SiH (Without EDTA) in Smart Touch vs H (With EDTA) in Smart Touch</title>
          <description>Participants received a Silicone Hydrogel lens (without EDTA) in Smart Touch packaging which was inserted in one eye and a Hydrogel lens (with EDTA) in Smart Touch packaging which was inserted in the other eye.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout (Minimum 48 Hours)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="0">Participants in this group were only assigned to one visit/intervention</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="0">Participants in this group were only assigned to one visit/intervention</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="0">Participants in this group were only assigned to one visit/intervention</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="0">Participants in this group were only assigned to one visit/intervention</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout (Minimum 48 Hours)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="0">Participants in this group were only assigned to one visit/intervention</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="0">Participants in this group were only assigned to one visit/intervention</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>13 participants exited study after first two visits/interventions</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Third Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="13">Participants in this group were only assigned to one visit/intervention</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="13">Participants in this group were only assigned to one visit/intervention</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>SiH (With EDTA) , Then H (no EDTA), Then SiH (Without EDTA) and H (With EDTA) in Smart Touch</title>
          <description>Participants first received a Silicone Hydrogel lens (with EDTA) in Smart Touch packaging which was inserted in one eye and a Silicone Hydrogel lens (with EDTA) in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours, they then received a Hydrogel lens (no EDTA) in Smart Touch packaging which was inserted in one eye and a Hydrogel lens in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours they then received a Silicone Hydrogel lens (without EDTA) in Smart Touch packaging in one eye and a Hydrogel lens (with EDTA) in Smart Touch packaging in the other eye.</description>
        </group>
        <group group_id="B2">
          <title>H (no EDTA), Then SiH (With EDTA), Then SiH (Without EDTA) vs H (With EDTA) in Smart Touch</title>
          <description>Participants first received a Hydrogel lens (no EDTA) in Smart Touch packaging which was inserted in one eye and a Hydrogel lens in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours, they then received a Silicone Hydrogel lens (with EDTA) in Smart Touch packaging which was inserted in one eye and a Silicone Hydrogel lens (with EDTA) in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours they then received a Silicone Hydrogel lens (without EDTA) in Smart Touch packaging in one eye and a Hydrogel lens (with EDTA) in Smart Touch packaging in the other eye.</description>
        </group>
        <group group_id="B3">
          <title>SiH (Without EDTA) in Smart Touch vs H (With EDTA) in Smart Touch</title>
          <description>Participants received a Silicone Hydrogel lens (without EDTA) in Smart Touch packaging which was inserted in one eye and a Hydrogel lens (with EDTA) in Smart Touch packaging which was inserted in the other eye.</description>
        </group>
        <group group_id="B4">
          <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="12"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="13"/>
            <count group_id="B4" value="38"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="29.8" spread="8.8"/>
                    <measurement group_id="B2" value="29.8" spread="8.8"/>
                    <measurement group_id="B3" value="30.1" spread="14.2"/>
                    <measurement group_id="B4" value="29.9" spread="10.8"/>
                  </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="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="12"/>
                  </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>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Without Contamination of Contact Lenses</title>
        <description>Number of Participants Without Contamination of Contact Lenses after 45 minutes of wear</description>
        <time_frame>After 45 minutes of lens wear</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Silicone Hydrogel (With EDTA) in Smart Touch</title>
            <description>Lens Contamination for Silicone Hydrogel lenses in Smart Touch™ (with EDTA).</description>
          </group>
          <group group_id="O2">
            <title>Silicone Hydrogel (With EDTA) in Conventional Packaging</title>
            <description>Lens Contamination for Silicone hydrogel (with EDTA) in conventional packaging</description>
          </group>
          <group group_id="O3">
            <title>Silicone Hydrogel (no EDTA) in Smart Touch</title>
            <description>Lens Contamination for Silicone Hydrogel lenses in Smart Touch™ (no EDTA).</description>
          </group>
          <group group_id="O4">
            <title>Hydrogel (no EDTA) in Smart Touch</title>
            <description>Lens Contamination for Hydrogel lenses in Smart Touch™ (no EDTA).</description>
          </group>
          <group group_id="O5">
            <title>Hydrogel (no EDTA) in Conventional Packaging</title>
            <description>Lens Contamination for Hydrogel in Conventional packaging (no EDTA).</description>
          </group>
          <group group_id="O6">
            <title>Hydrogel (With EDTA) in Smart Touch</title>
            <description>Lens Contamination for Hydrogel lenses in Smart Touch™ (with EDTA).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Without Contamination of Contact Lenses</title>
          <description>Number of Participants Without Contamination of Contact Lenses after 45 minutes of wear</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="25"/>
                <count group_id="O5" value="25"/>
                <count group_id="O6" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="14"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bacterial Counts of Worn Contact Lenses</title>
        <description>Bacterial counts of contact lenses after 45 minutes of wear (CFU count /lens)</description>
        <time_frame>After 45 minutes of lens wear</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Silicone Hydrogel (With EDTA) in Smart Touch</title>
            <description>Lens Contamination for Silicone Hydrogel lenses in Smart Touch™ (with EDTA).</description>
          </group>
          <group group_id="O2">
            <title>Silicone Hydrogel (With EDTA) in Conventional Packaging</title>
            <description>Lens Contamination for Silicone hydrogel (with EDTA) in conventional packaging</description>
          </group>
          <group group_id="O3">
            <title>Silicone Hydrogel (no EDTA) in Smart Touch</title>
            <description>Lens Contamination for Silicone Hydrogel lenses in Smart Touch™ (no EDTA).</description>
          </group>
          <group group_id="O4">
            <title>Hydrogel (no EDTA) in Smart Touch</title>
            <description>Lens Contamination for Hydrogel lenses in Smart Touch™ (no EDTA).</description>
          </group>
          <group group_id="O5">
            <title>Hydrogel (no EDTA) in Conventional Packaging</title>
            <description>Lens Contamination for Hydrogel in Conventional packaging (no EDTA).</description>
          </group>
          <group group_id="O6">
            <title>Hydrogel (With EDTA) in Smart Touch</title>
            <description>Lens Contamination for Hydrogel lenses in Smart Touch™ (with EDTA).</description>
          </group>
        </group_list>
        <measure>
          <title>Bacterial Counts of Worn Contact Lenses</title>
          <description>Bacterial counts of contact lenses after 45 minutes of wear (CFU count /lens)</description>
          <units>CFU count per lens</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <units_analyzed>Lens</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="25"/>
                <count group_id="O5" value="25"/>
                <count group_id="O6" value="25"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lens</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="25"/>
                <count group_id="O5" value="25"/>
                <count group_id="O6" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="43"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="25"/>
                    <measurement group_id="O3" value="4" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="17"/>
                    <measurement group_id="O5" value="1" lower_limit="0" upper_limit="16"/>
                    <measurement group_id="O6" value="0" lower_limit="0" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Participants were monitored for adverse events occurring during lens wear i.e. 45 minutes for each visit, up to 3 visits.</time_frame>
      <desc>Participants were monitored for adverse events at each visit</desc>
      <group_list>
        <group group_id="E1">
          <title>Silicone Hydrogel (With EDTA) in Smart Touch</title>
          <description>Lens Contamination for Silicone Hydrogel lenses in Smart Touch™ (with EDTA).</description>
        </group>
        <group group_id="E2">
          <title>Silicone Hydrogel (With EDTA) in Conventional Packaging</title>
          <description>Lens Contamination for Silicone hydrogel (with EDTA) in conventional packaging</description>
        </group>
        <group group_id="E3">
          <title>Silicone Hydrogel (no EDTA) in Smart Touch</title>
          <description>Lens Contamination for Silicone Hydrogel lenses in Smart Touch™ (no EDTA).</description>
        </group>
        <group group_id="E4">
          <title>Hydrogel (no EDTA) in Smart Touch</title>
          <description>Lens Contamination for Hydrogel lenses in Smart Touch™ (no EDTA).</description>
        </group>
        <group group_id="E5">
          <title>Hydrogel (no EDTA) in Conventional Packaging</title>
          <description>Lens Contamination for Hydrogel in Conventional packaging (no EDTA).</description>
        </group>
        <group group_id="E6">
          <title>Hydrogel (With EDTA) in Smart Touch</title>
          <description>Lens Contamination for Hydrogel lenses in Smart Touch™ (with EDTA).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <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="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
              </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="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Jacqueline Tan</name_or_title>
      <organization>University of New South Wales</organization>
      <phone>+612 9385 6551</phone>
      <email>jacqueline.tan@unsw.edu.au</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/NCT03253393
org study id: SOVS2017-050
nct id: NCT03253393
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study is a randomized, contralateral, investigator-masked non-dispensing study, to
      investigate the microbial contamination rates on the back surface of two types of soft
      contact lenses (hydrogel and silicone hydrogel) extracted from Smart Touch Technology blister
      packs versus conventional lens packaging after short-term placement on the eye, and to
      compare the microbial contamination rates of the worn contact lenses to those on the
      participants' hands/fingers used to conduct lens insertion.
This will be a prospective, single centre, randomized, contralateral, investigator-masked
      non-dispensing study. This study requires three visits of approx. 1 hour duration each.

      At the first visit, the order in which the hydrogel (no EDTA) and silicone hydrogel (with
      EDTA) contact lenses are allocated to the study participants will be randomized. At the
      second visit, participants will be crossed over to the alternate lens type (hydrogel no EDTA
      or silicone hydrogel with EDTA).

      At the third visit, participants will be randomly allocated to wear the hydrogel lens (with
      EDTA) in one eye and the silicone hydrogel lens (no EDTA) in the other eye, both removed from
      Smart Touch Technology packaging.

      At each visit, participants will be instructed to:

        -  Wash their hands prior to handling the contact lenses;

        -  Swab their thumb and two index fingers of the hand routinely used to conduct contact
           lens insertion using a sterile cotton swab moistened with sterile preservative free
           saline for the evaluation of skin microbiota;

        -  Follow the manufacturer's guidelines for lens insertion;

        -  Open the blister pack and insert the contact lens randomly assigned for the right eye;

        -  Open the blister pack and insert the contact lens assigned for the left eye;

        -  Contact lenses will be removed aseptically by a masked investigator after 45 minutes of
           lens wear.

      Lenses and finger swabs will be analysed for microbial contamination using established
      routine microbiology protocols. The number and species of organisms will be determined.

      A minimum washout period of 48 hours will occur between the study visits.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Contralateral study
primary purpose: Basic Science
masking: Single (Investigator)
measure: Number of Participants Without Contamination of Contact Lenses
time frame: After 45 minutes of lens wear
description: Number of Participants Without Contamination of Contact Lenses after 45 minutes of wear
measure: Bacterial Counts of Worn Contact Lenses
time frame: After 45 minutes of lens wear
description: Bacterial counts of contact lenses after 45 minutes of wear (CFU count /lens)
arm group label: Silicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging
arm group type: Experimental
description: Silicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging
arm group label: Hydrogel (no EDTA) in Smart Touch vs. in conventional packaging
arm group type: Experimental
description: Hydrogel (no EDTA) in Smart Touch vs. in conventional packaging
arm group label: Silicone hydrogel (no EDTA) vs. hydrogel (with EDTA) in Smart Touch
arm group type: Experimental
description: Silicone hydrogel (no EDTA) vs. hydrogel (with EDTA) in Smart Touch
intervention type: Device
intervention name: Smart Touch Technology packaging
description: hioxifilcon A contact lens in Smart Touch Technology (hydrogel, no EDTA) midafilcon A contact lens in Smart Touch Technology (silicone hydrogel, with EDTA)
arm group label: Hydrogel (no EDTA) in Smart Touch vs. in conventional packaging
arm group label: Silicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging
intervention type: Device
intervention name: Conventional lens packaging
description: hioxifilcon A contact lens in conventional lens packaging (hydrogel, no EDTA) midafilcon A contact lens in conventional lens packaging (silicone hydrogel, with EDTA)
arm group label: Hydrogel (no EDTA) in Smart Touch vs. in conventional packaging
arm group label: Silicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging
intervention type: Device
intervention name: EDTA
description: hioxifilcon A contact lens in Smart Touch Technology (hydrogel, with EDTA) midafilcon A contact lens in Smart Touch Technology (silicone hydrogel, no EDTA)
arm group label: Silicone hydrogel (no EDTA) vs. hydrogel (with EDTA) in Smart Touch
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Australia
responsible party type: Principal Investigator
investigator affiliation: The University of New South Wales
investigator full name: Jacqueline Tan-Showyin
investigator title: Senior Research Fellow
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 