<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/NCT03034928</url>
  </required_header>
  <id_info>
    <org_study_id>CLY935-E002</org_study_id>
    <nct_id>NCT03034928</nct_id>
  </id_info>
  <brief_title>Clinical Biocompatibility Evaluation of Contact Lens Coatings</brief_title>
  <official_title>Clinical Biocompatibility Evaluation of Contact Lens Coatings</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is to evaluate corneal staining observed after 2 hours of wear with&#xD;
      contact lenses with investigational coating against PureVision™ lenses, all pre-cycled with&#xD;
      OPTI-FREE® RepleniSH® multi-purpose disinfection solution.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this contralateral crossover study, qualifying subjects will wear a total of 2 pairs of&#xD;
      study contact lenses. Lenses will be worn according to a randomized lens sequence assignment.&#xD;
      Each pair will consist of a test lens (Test 1 or Test 2) and a control lens.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 14, 2017</start_date>
  <completion_date type="Actual">March 14, 2017</completion_date>
  <primary_completion_date type="Actual">March 14, 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average Percent Area of Solution-related Corneal Staining</measure>
    <time_frame>Day 1 after 2 hours of wear, each product</time_frame>
    <description>Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. A higher percentage reflects more damage to the corneal surface. Both eyes contributed to the analysis. No hypotheses were formulated; no inferences were made and only descriptive statistics were used in the reporting.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Refractive Errors</condition>
  <condition>Ametropia</condition>
  <arm_group>
    <arm_group_label>Test 1/Control 1, then Control 2/Test 2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test 2/Control 2, then Control 1/Test 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control 1/Test 1, then Test 2/Control 2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 1, followed by contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control 2/Test 2, then Test 1/Control 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 1, followed by contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Contact lens with investigational coating 1</intervention_name>
    <description>Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)</description>
    <arm_group_label>Control 1/Test 1, then Test 2/Control 2</arm_group_label>
    <arm_group_label>Control 2/Test 2, then Test 1/Control 1</arm_group_label>
    <arm_group_label>Test 1/Control 1, then Control 2/Test 2</arm_group_label>
    <arm_group_label>Test 2/Control 2, then Control 1/Test 1</arm_group_label>
    <other_name>Test 1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Balafilcon A contact lens</intervention_name>
    <description>Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS</description>
    <arm_group_label>Control 1/Test 1, then Test 2/Control 2</arm_group_label>
    <arm_group_label>Control 2/Test 2, then Test 1/Control 1</arm_group_label>
    <arm_group_label>Test 1/Control 1, then Control 2/Test 2</arm_group_label>
    <arm_group_label>Test 2/Control 2, then Control 1/Test 1</arm_group_label>
    <other_name>Bausch &amp; Lomb PureVision™</other_name>
    <other_name>Control 1</other_name>
    <other_name>Control 2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OPTI-FREE® RepleniSH® MPDS</intervention_name>
    <description>Multipurpose contact lens solution</description>
    <arm_group_label>Control 1/Test 1, then Test 2/Control 2</arm_group_label>
    <arm_group_label>Control 2/Test 2, then Test 1/Control 1</arm_group_label>
    <arm_group_label>Test 1/Control 1, then Control 2/Test 2</arm_group_label>
    <arm_group_label>Test 2/Control 2, then Control 1/Test 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Contact lens with investigational coating 2</intervention_name>
    <description>Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS</description>
    <arm_group_label>Control 1/Test 1, then Test 2/Control 2</arm_group_label>
    <arm_group_label>Control 2/Test 2, then Test 1/Control 1</arm_group_label>
    <arm_group_label>Test 1/Control 1, then Control 2/Test 2</arm_group_label>
    <arm_group_label>Test 2/Control 2, then Control 1/Test 1</arm_group_label>
    <other_name>Test 2</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to understand and must sign an Informed Consent;&#xD;
&#xD;
          -  Successful wearer of spherical soft contact lenses in both eyes for a minimum of 5&#xD;
             days per week and 8 hours per day during the past 3 months;&#xD;
&#xD;
          -  Manifest cylinder less than or equal to 1.50 diopter (D) in each eye;&#xD;
&#xD;
          -  Best Corrected Visual Acuity (BCVA) 20/25 or better in each eye;&#xD;
&#xD;
          -  VA with habitual spectacles 20/40 in both eyes (OU) or better and willing to wear&#xD;
             spectacles as needed during the washout period and during study lens exposure;&#xD;
&#xD;
          -  Other protocol-specified inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any anterior segment infection, inflammation, abnormality or disease that&#xD;
             contraindicates contact lens wear;&#xD;
&#xD;
          -  Any use of systemic or ocular medications for which contact lens wear could be&#xD;
             contraindicated;&#xD;
&#xD;
          -  History of refractive surgery or plan to have refractive surgery during the study or&#xD;
             irregular cornea in either eye;&#xD;
&#xD;
          -  Ocular or intra-ocular surgery (excluding placement of punctal plugs) within the&#xD;
             previous 12 months or planned during the study;&#xD;
&#xD;
          -  Current or history of pathologically dry eye in either eye that would preclude contact&#xD;
             lens wear;&#xD;
&#xD;
          -  Current or history of herpetic keratitis in either eye;&#xD;
&#xD;
          -  Eye injury in either eye within 12 weeks immediately prior to enrollment;&#xD;
&#xD;
          -  History of intolerance or hypersensitivity to any component of the study lenses or&#xD;
             solutions;&#xD;
&#xD;
          -  Habitual contact lenses worn in an extended wear modality (routinely sleeping in&#xD;
             lenses for at least 1 night per week) over the last 3 months prior to enrollment;&#xD;
&#xD;
          -  Use of topical ocular medications and artificial tear or rewetting drops that would&#xD;
             require instillation during contact lens wear;&#xD;
&#xD;
          -  Other protocol-specified 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>Sr. Clinical Manager, Trial Management Operations</last_name>
    <role>Study Director</role>
    <affiliation>Alcon, A Novartis Division</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alcon Investigative Site</name>
      <address>
        <city>Johns Creek</city>
        <state>Georgia</state>
        <zip>30097</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <results_first_submitted>February 5, 2020</results_first_submitted>
  <results_first_submitted_qc>February 5, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 18, 2020</results_first_posted>
  <disposition_first_submitted>February 13, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>March 5, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">February 18, 2020</disposition_first_posted>
  <last_update_submitted>February 5, 2020</last_update_submitted>
  <last_update_submitted_qc>February 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Refractive Errors</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 9, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03034928/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 5, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03034928/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited from 1 study center located in the United States (US).</recruitment_details>
      <pre_assignment_details>All 33 subjects enrolled were randomized. This reporting group includes all randomized subjects (33).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Test 1/Control 1, Then Control 2/Test 2</title>
          <description>Contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.</description>
        </group>
        <group group_id="P2">
          <title>Test 2/Control 2, Then Control 1/Test 1</title>
          <description>Contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.</description>
        </group>
        <group group_id="P3">
          <title>Control 1/Test 1, Then Test 2/Control 2</title>
          <description>Balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 1, followed by contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.</description>
        </group>
        <group group_id="P4">
          <title>Control 2/Test 2, Then Test 1/Control 1</title>
          <description>Balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 1, followed by contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1, First 2 Hours of Wear</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="8"/>
              </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 group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout Period Between Lens Wear</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="8"/>
              </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 group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 2, Second 2 Hours of Wear</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="8"/>
              </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 group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>This analysis population includes all subjects exposed to any study lens (Safety Analysis Set).</population>
      <group_list>
        <group group_id="B1">
          <title>Overall</title>
          <description>Contact lens with investigational coatings and balafilcon A contact lens worn contralaterally during Period 1 and Period 2.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="33"/>
          </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="46.9" spread="14.46"/>
                  </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="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </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>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multi-Racial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Average Percent Area of Solution-related Corneal Staining</title>
        <description>Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. A higher percentage reflects more damage to the corneal surface. Both eyes contributed to the analysis. No hypotheses were formulated; no inferences were made and only descriptive statistics were used in the reporting.</description>
        <time_frame>Day 1 after 2 hours of wear, each product</time_frame>
        <population>This analysis population includes all randomized subjects who satisfied protocol-specified criteria (Full Analysis Set).</population>
        <group_list>
          <group group_id="O1">
            <title>Test 1</title>
            <description>Contact lens with investigational coating 1 worn for approximately 2 hours during Period 1 or Period 2</description>
          </group>
          <group group_id="O2">
            <title>Control 1</title>
            <description>Balafilcon A contact lens worn contralaterally to Test 1 for approximately 2 hours during Period 1 or Period 2</description>
          </group>
          <group group_id="O3">
            <title>Test 2</title>
            <description>Contact lens with investigational coating 2 worn for approximately 2 hours during Period 1 or Period 2</description>
          </group>
          <group group_id="O4">
            <title>Control 2</title>
            <description>Balafilcon A contact lens worn contralaterally to Test 2 for approximately 2 hours during Period 1 or Period 2</description>
          </group>
        </group_list>
        <measure>
          <title>Average Percent Area of Solution-related Corneal Staining</title>
          <description>Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. A higher percentage reflects more damage to the corneal surface. Both eyes contributed to the analysis. No hypotheses were formulated; no inferences were made and only descriptive statistics were used in the reporting.</description>
          <population>This analysis population includes all randomized subjects who satisfied protocol-specified criteria (Full Analysis Set).</population>
          <units>percentage of area</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="33"/>
                <count group_id="O4" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.01" spread="10.54"/>
                    <measurement group_id="O2" value="12.82" spread="17.93"/>
                    <measurement group_id="O3" value="13.54" spread="17.20"/>
                    <measurement group_id="O4" value="7.58" spread="10.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline through study completion, approximately 8 days</time_frame>
      <desc>An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Safety Analysis Set, based on treatment-specific exposure.</desc>
      <group_list>
        <group group_id="E1">
          <title>Test 1</title>
          <description>All subjects exposed to contact lens with investigational coating 1 during Period 1 or Period 2</description>
        </group>
        <group group_id="E2">
          <title>Test 2</title>
          <description>All subjects exposed to contact lens with investigational coating 2 during Period 1 or Period 2</description>
        </group>
        <group group_id="E3">
          <title>Control</title>
          <description>All subjects exposed to balafilcon A contact lens during Period 1 or Period 2</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="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
              </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="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Sr CDMA Project Lead, GCRA - Vision Care</name_or_title>
      <organization>Alcon, A Novartis Division</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/NCT03034928
org study id: CLY935-E002
nct id: NCT03034928
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The primary objective is to evaluate corneal staining observed after 2 hours of wear with
      contact lenses with investigational coating against PureVision™ lenses, all pre-cycled with
      OPTI-FREE® RepleniSH® multi-purpose disinfection solution.
In this contralateral crossover study, qualifying subjects will wear a total of 2 pairs of
      study contact lenses. Lenses will be worn according to a randomized lens sequence assignment.
      Each pair will consist of a test lens (Test 1 or Test 2) and a control lens.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Average Percent Area of Solution-related Corneal Staining
time frame: Day 1 after 2 hours of wear, each product
description: Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. A higher percentage reflects more damage to the corneal surface. Both eyes contributed to the analysis. No hypotheses were formulated; no inferences were made and only descriptive statistics were used in the reporting.
arm group label: Test 1/Control 1, then Control 2/Test 2
arm group type: Other
description: Contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
arm group label: Test 2/Control 2, then Control 1/Test 1
arm group type: Other
description: Contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
arm group label: Control 1/Test 1, then Test 2/Control 2
arm group type: Other
description: Balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 1, followed by contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
arm group label: Control 2/Test 2, then Test 1/Control 1
arm group type: Other
description: Balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 1, followed by contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
intervention type: Device
intervention name: Contact lens with investigational coating 1
description: Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)
arm group label: Control 1/Test 1, then Test 2/Control 2
arm group label: Control 2/Test 2, then Test 1/Control 1
arm group label: Test 1/Control 1, then Control 2/Test 2
arm group label: Test 2/Control 2, then Control 1/Test 1
other name: Test 1
intervention type: Device
intervention name: Balafilcon A contact lens
description: Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS
arm group label: Control 1/Test 1, then Test 2/Control 2
arm group label: Control 2/Test 2, then Test 1/Control 1
arm group label: Test 1/Control 1, then Control 2/Test 2
arm group label: Test 2/Control 2, then Control 1/Test 1
other name: Bausch & Lomb PureVision™
other name: Control 1
other name: Control 2
intervention type: Device
intervention name: OPTI-FREE® RepleniSH® MPDS
description: Multipurpose contact lens solution
arm group label: Control 1/Test 1, then Test 2/Control 2
arm group label: Control 2/Test 2, then Test 1/Control 1
arm group label: Test 1/Control 1, then Control 2/Test 2
arm group label: Test 2/Control 2, then Control 1/Test 1
intervention type: Device
intervention name: Contact lens with investigational coating 2
description: Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS
arm group label: Control 1/Test 1, then Test 2/Control 2
arm group label: Control 2/Test 2, then Test 1/Control 1
arm group label: Test 1/Control 1, then Control 2/Test 2
arm group label: Test 2/Control 2, then Control 1/Test 1
other name: Test 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sr. Clinical Manager, Trial Management Operations
role: Study Director
affiliation: Alcon, A Novartis Division
facility: 
country: United States
responsible party type: Sponsor
mesh term: Refractive Errors
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 