<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/NCT04403542</url>
  </required_header>
  <id_info>
    <org_study_id>CLY935-C008</org_study_id>
    <nct_id>NCT04403542</nct_id>
  </id_info>
  <brief_title>Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear</brief_title>
  <official_title>Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear</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 purpose of this clinical study is to evaluate the on-eye performance of an&#xD;
      investigational soft contact lens compared to a commercially available soft contact lens when&#xD;
      worn continuously for up to 1 week.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be randomized to wear the investigational contact lens in 1 eye and the&#xD;
      commercially available contact lens in the other eye. Subjects will be expected to attend 3&#xD;
      scheduled study visits: Day 1 Screening/Baseline/Dispense; Day 2 Follow-up within 4 hours of&#xD;
      awakening (after the first night of sleeping); and Week 1 Follow-up/Exit. The expected&#xD;
      duration of exposure to each of the study lenses for all randomized, completed subjects was&#xD;
      approximately 7 days / 6 nights of wear.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2020</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 31, 2020</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>
    <intervention_model_description>In this contralateral study, subjects will be randomized to wear the investigational lens in 1 eye and the control lens in the other eye.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Distance Visual Acuity (VA) With Study Lenses</measure>
    <time_frame>Day 1 Dispense; Day 2 Follow-up (within 4 hours of awakening); Week 1 Follow-up/Exit</time_frame>
    <description>Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Refractive Errors</condition>
  <condition>Myopia</condition>
  <condition>Hyperopia</condition>
  <arm_group>
    <arm_group_label>LID018869 (OD) / Biofinity (OS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lehfilcon A contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biofinity (OD) / LID018869 (OS)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Comfilcon A contact lens worn in the right eye, with lehfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lehfilcon A contact lens</intervention_name>
    <description>Investigational silicone hydrogel contact lens</description>
    <arm_group_label>Biofinity (OD) / LID018869 (OS)</arm_group_label>
    <arm_group_label>LID018869 (OD) / Biofinity (OS)</arm_group_label>
    <other_name>LID018869</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Comfilcon A contact lens</intervention_name>
    <description>Commercially available silicone hydrogel contact lens</description>
    <arm_group_label>Biofinity (OD) / LID018869 (OS)</arm_group_label>
    <arm_group_label>LID018869 (OD) / Biofinity (OS)</arm_group_label>
    <other_name>Biofinity</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Able to understand and sign an IRB/IEC approved Informed Consent form.&#xD;
&#xD;
          -  Successful wear of spherical soft contact lenses in both eyes during the past 3 months&#xD;
             for a minimum of 5 days/week and in an extended wear modality at least 1 night/week.&#xD;
&#xD;
          -  Best corrected visual acuity of 20/25 or better in each eye.&#xD;
&#xD;
          -  Other protocol-specified inclusion criteria may apply.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Any condition, use of medications, or surgery that could contraindicate contact lens&#xD;
             wear, as determined by the Investigator.&#xD;
&#xD;
          -  Any habitual wear of Biofinity contact lenses.&#xD;
&#xD;
          -  Pregnant or breast-feeding.&#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>CDMA Project Lead, Vision Care</last_name>
    <role>Study Director</role>
    <affiliation>Alcon Research, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alcon Investigator 6402</name>
      <address>
        <city>Medina</city>
        <state>Minnesota</state>
        <zip>55340</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigator 8046</name>
      <address>
        <city>Granville</city>
        <state>Ohio</state>
        <zip>43023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcon Investigator 2786</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <results_first_submitted>July 27, 2023</results_first_submitted>
  <results_first_submitted_qc>August 18, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 22, 2023</results_first_posted>
  <disposition_first_submitted>August 23, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>August 18, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 22, 2023</disposition_first_posted>
  <last_update_submitted>August 18, 2023</last_update_submitted>
  <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Extended Wear</keyword>
  <keyword>Contact Lens</keyword>
  <keyword>Overnight Wear</keyword>
  <keyword>Vision Correction</keyword>
  <keyword>Contralateral Wear</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Refractive Errors</mesh_term>
    <mesh_term>Hyperopia</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>May 14, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT04403542/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>July 21, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT04403542/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited from 3 investigative sites located in the United States.</recruitment_details>
      <pre_assignment_details>This reporting group includes all enrolled subjects.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>LID018869 (OD) / Biofinity (OS)</title>
          <description>Lehfilcon A contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear</description>
        </group>
        <group group_id="P2">
          <title>Biofinity (OD) / LID018869 (OS)</title>
          <description>Comfilcon A contact lens worn in the right eye, with lehfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="18"/>
              </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>Safety Analysis Set: All eyes exposed any study lens on a treatment-emergent basis</population>
      <group_list>
        <group group_id="B1">
          <title>LID018869 (OD) / Biofinity (OS)</title>
          <description>Lehfilcon A contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear</description>
        </group>
        <group group_id="B2">
          <title>Biofinity (OD) / LID018869 (OS)</title>
          <description>Comfilcon A contact lens worn in the right eye, with lehfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear</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="18"/>
            <count group_id="B2" value="18"/>
            <count group_id="B3" value="36"/>
          </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="32.4" spread="7.9"/>
                    <measurement group_id="B2" value="33.9" spread="10.5"/>
                    <measurement group_id="B3" value="33.2" spread="9.2"/>
                  </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="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Distance Visual Acuity (VA) With Study Lenses</title>
        <description>Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.</description>
        <time_frame>Day 1 Dispense; Day 2 Follow-up (within 4 hours of awakening); Week 1 Follow-up/Exit</time_frame>
        <population>Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>LID018869</title>
            <description>Lehfilcon A contact lens worn in the right eye or left eye, as randomized, for approximately 1 week of continuous wear</description>
          </group>
          <group group_id="O2">
            <title>Biofinity</title>
            <description>Comfilcon A contact lens worn in the right eye or left eye, as randomized, for approximately 1 week of continuous wear</description>
          </group>
        </group_list>
        <measure>
          <title>Distance Visual Acuity (VA) With Study Lenses</title>
          <description>Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.</description>
          <population>Safety Analysis Set</population>
          <units>logMAR</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="36"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 Dispense</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="0.05"/>
                    <measurement group_id="O2" value="-0.04" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2 Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="0.05"/>
                    <measurement group_id="O2" value="-0.03" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 Follow-up/Exit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="0.05"/>
                    <measurement group_id="O2" value="-0.03" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AE's) were collected from time of consent to study exit, approximately 7 days.</time_frame>
      <desc>AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. &quot;At Risk&quot; population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. The safety analysis set includes all eyes exposed to a study lens evaluated in this study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Pretreatment</title>
          <description>Events reported in this group occurred prior to exposure to the study contact lenses</description>
        </group>
        <group group_id="E2">
          <title>LID018869 Ocular</title>
          <description>Events reported in this group occurred while exposed to the lehfilcon A contact lenses</description>
        </group>
        <group group_id="E3">
          <title>Biofinity Ocular</title>
          <description>Events reported in this group occurred while exposed to the comfilcon A contact lenses</description>
        </group>
        <group group_id="E4">
          <title>Nonocular/Systemic</title>
          <description>Events reported in this group occurred while exposed to the study contact lenses</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="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="36"/>
              </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="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="36"/>
              </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>CDMA Project Lead, Vision Care</name_or_title>
      <organization>Alcon Research, LLC</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/NCT04403542
org study id: CLY935-C008
nct id: NCT04403542
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The purpose of this clinical study is to evaluate the on-eye performance of an
      investigational soft contact lens compared to a commercially available soft contact lens when
      worn continuously for up to 1 week.
Subjects will be randomized to wear the investigational contact lens in 1 eye and the
      commercially available contact lens in the other eye. Subjects will be expected to attend 3
      scheduled study visits: Day 1 Screening/Baseline/Dispense; Day 2 Follow-up within 4 hours of
      awakening (after the first night of sleeping); and Week 1 Follow-up/Exit. The expected
      duration of exposure to each of the study lenses for all randomized, completed subjects was
      approximately 7 days / 6 nights of wear.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In this contralateral study, subjects will be randomized to wear the investigational lens in 1 eye and the control lens in the other eye.
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Distance Visual Acuity (VA) With Study Lenses
time frame: Day 1 Dispense; Day 2 Follow-up (within 4 hours of awakening); Week 1 Follow-up/Exit
description: Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
arm group label: LID018869 (OD) / Biofinity (OS)
arm group type: Experimental
description: Lehfilcon A contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear
arm group label: Biofinity (OD) / LID018869 (OS)
arm group type: Active Comparator
description: Comfilcon A contact lens worn in the right eye, with lehfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear
intervention type: Device
intervention name: Lehfilcon A contact lens
description: Investigational silicone hydrogel contact lens
arm group label: Biofinity (OD) / LID018869 (OS)
arm group label: LID018869 (OD) / Biofinity (OS)
other name: LID018869
intervention type: Device
intervention name: Comfilcon A contact lens
description: Commercially available silicone hydrogel contact lens
arm group label: Biofinity (OD) / LID018869 (OS)
arm group label: LID018869 (OD) / Biofinity (OS)
other name: Biofinity
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: CDMA Project Lead, Vision Care
role: Study Director
affiliation: Alcon Research, LLC
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Refractive Errors
mesh term: Hyperopia
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 