<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/NCT01706770</url>
  </required_header>
  <id_info>
    <org_study_id>FC111216</org_study_id>
    <nct_id>NCT01706770</nct_id>
  </id_info>
  <brief_title>Evaluation of Enfilcon A Soft Contact Lens When Compared to Galyfilcon A Soft Contact Lens</brief_title>
  <official_title>Evaluation of Enfilcon A Soft Contact Lens Compared to Galyfilcon A Soft Contact Lens</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coopervision, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Coopervision, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of thes study is to confirm that the ocular response to the Test lenses&#xD;
      are similar to those of the Control lenses when used in a 1 week planned replacement, daily&#xD;
      wear modality over a 1-month period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The test lens and control lens were randomized in a 2:1 ratio to evaluate the test lens and&#xD;
      control contact lens.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Assessment: Ocular Response - Biomicroscopy</measure>
    <time_frame>Change from baseline/dispensing visits, post-dispensing visit and all follow-ups visits</time_frame>
    <description>The primary safety endpoint are the objective slit lamp findings associated with the enfilcon A contact lenses compared with those same findings reported as associated with the galyfilcon A contact lenses.&#xD;
The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline/Dispensing (baseline and dispensing visit combined), Post-Dispensing (after lenses were dispensed and allowed to settle) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit combined). The average grade for unique eyes with findings greater than 0 (none) is compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of Objective Findings - Number of Adverse Events in Unique Eyes</measure>
    <time_frame>Any occurrence from baseline to 1 month visit</time_frame>
    <description>The primary safety endpoint are the objective findings of the number of adverse events in unique eyes associated with the enfilcon A contact lenses compared with those same findings as associated with the galyfilcon A contact lenses.&#xD;
The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence from Baseline through end of month 1 visit.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Ametropia</condition>
  <arm_group>
    <arm_group_label>enfilcon A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>galyfilcon A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>enfilcon A</intervention_name>
    <arm_group_label>enfilcon A</arm_group_label>
    <other_name>Avaira® Toric</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>galyfilcon A</intervention_name>
    <arm_group_label>galyfilcon A</arm_group_label>
    <other_name>Acvuve® Advance®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Prior to being considered eligible to participate in this study, each subject MUST:&#xD;
&#xD;
          -  Be at least 18 years of age as of the date of evaluation for the study.&#xD;
&#xD;
          -  Have read the Informed Consent, been given an explanation of the Informed Consent,&#xD;
             indicated understanding of the Informed Consent, signed the Informed Consent document.&#xD;
&#xD;
          -  Be willing and able to adhere to the instructions set forth in this protocol and able&#xD;
             to keep all specified appointments.&#xD;
&#xD;
          -  Be an adapted, current full-time silicone hydrogel or soft contact lens wearer. An&#xD;
             adapted full-time wearer is defined as wearing contact lenses in both eyes on a daily&#xD;
             basis for at least 8 hours per day for at least one month prior to participation in&#xD;
             the study.&#xD;
&#xD;
          -  Possess wearable and visually functional eyeglasses.&#xD;
&#xD;
          -  Be in good general health, based on his/her knowledge.&#xD;
&#xD;
          -  Require spectacle lens powers between -1.00 and -6.00 diopters sphere with no more&#xD;
             than 2.00 diopters of refractive astigmatism and be willing to wear contact lenses in&#xD;
             both eyes.&#xD;
&#xD;
          -  Have: manifest refraction Snellen visual acuities (VA) equal to or better than 20/25&#xD;
             in each eye.&#xD;
&#xD;
          -  Upon completing the fitting process with the lenses to be worn in the study, have&#xD;
             contact lens Snellen VA equal to or better than 20/30 in each eye.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects may not be enrolled in this study if any of the following apply: The subject&#xD;
        is/has:&#xD;
&#xD;
          -  Wearing lenses in a monovision modality and is unwilling to be fit with distance&#xD;
             lenses in both eyes. NOTE: Subjects may not wear lenses in a monovision modality at&#xD;
             any time during the study as it will interfere with the visual acuity analysis.&#xD;
&#xD;
          -  Poor personal hygiene.&#xD;
&#xD;
          -  Any active participation in another clinical trial within 30 days prior to this study.&#xD;
&#xD;
          -  Currently pregnant (to the best of the subject's knowledge), is lactating or is&#xD;
             planning a pregnancy within the study period.&#xD;
&#xD;
          -  A member, relative or household member of the investigator or of the investigational&#xD;
             office staff.&#xD;
&#xD;
          -  Has a known sensitivity to ingredients used in the care products approved for use in&#xD;
             the study.&#xD;
&#xD;
          -  Previous refractive surgery; or current or previous orthokeratology treatment.&#xD;
&#xD;
          -  Is aphakic or psuedophakic.&#xD;
&#xD;
          -  Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis&#xD;
             (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermia,&#xD;
             keratoconus or type II diabetes.&#xD;
&#xD;
          -  The need for topical ocular medications or any medication which might interfere with&#xD;
             contact lens wear or which would require the lenses to be removed during the day.&#xD;
&#xD;
          -  The presence of clinically significant (grade 3 or 4) anterior segment abnormalities.&#xD;
&#xD;
          -  Any; inflammations such as iritis; or any infection or allergic reaction of the eye,&#xD;
             lids, or associated structures.&#xD;
&#xD;
          -  A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer,&#xD;
             corneal infiltrates or fungal infections.&#xD;
&#xD;
          -  A history of papillary conjunctivitis that has interfered with contact lens wear.&#xD;
&#xD;
          -  Slit lamp findings that would contraindicate contact lens wear, including but not&#xD;
             limited to: Pathological dry eye or associated dry eye symptoms with decreased tear&#xD;
             levels and punctuate staining &gt; Grade 2, Pterygium, Corneal scars within the visual&#xD;
             axis, Neovascularization or ghost vessels &gt; 1.0 mm in from the limbus, Giant papillary&#xD;
             conjunctivitis (GPC) of &gt; Grade 1, Anterior uveitis or iritis, Seborrheic eczema,&#xD;
             seborrheic conjunctivitis or blepharitis&#xD;
&#xD;
        To be eligible to be randomized for study product a subject must have ALL of the Inclusion&#xD;
        Criteria and have NONE of the exclusion criteria present.&#xD;
&#xD;
        To be eligible for lens dispensing (either Test or Control), the subject's study lens&#xD;
        contact lens visual acuity must be equal to or better than 20/30 in each eye.&#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>
  <overall_official>
    <last_name>Scott E Schachter, OD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unafiliated</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cheryl Vincent-Reimer, OD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unafiliated</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eric White, OD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unafiliated</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Advanced Eyecare</name>
      <address>
        <city>Pismo Beach</city>
        <state>California</state>
        <zip>93449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eric M. White, OD, Inc.</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>48823</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vision Care Associates</name>
      <address>
        <city>East Lansing</city>
        <state>Michigan</state>
        <zip>48823</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <results_first_submitted>October 22, 2013</results_first_submitted>
  <results_first_submitted_qc>March 28, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 29, 2014</results_first_posted>
  <last_update_submitted>September 11, 2020</last_update_submitted>
  <last_update_submitted_qc>September 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 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>

  <clinical_results>

    <participant_flow>
      <recruitment_details>52 subjects evaluated. Of these 52 subjects, 2 found ineligible and not randomized resulting in 50 subjects randomized, 33 test, 17 control. Of 50 subjects randomized, 2 discontinued and not included in results data, 31 test, 17 control, 1 lost to follow-up, 1 Sponsor/IRB decision due to pregnancy at one month visit.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Enfilcon A</title>
          <description>The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.</description>
        </group>
        <group group_id="P2">
          <title>Galyfilcon A</title>
          <description>The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Enfilcon A</title>
          <description>The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.</description>
        </group>
        <group group_id="B2">
          <title>Galyfilcon A</title>
          <description>The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.</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="33"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="50"/>
          </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="50"/>
                  </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="0"/>
                  </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="34.8" spread="11.11"/>
                    <measurement group_id="B2" value="33.8" spread="11.50"/>
                    <measurement group_id="B3" value="34.4" spread="11.13"/>
                  </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="23"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="15"/>
                  </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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Objective Assessment: Ocular Response - Biomicroscopy</title>
        <description>The primary safety endpoint are the objective slit lamp findings associated with the enfilcon A contact lenses compared with those same findings reported as associated with the galyfilcon A contact lenses.&#xD;
The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline/Dispensing (baseline and dispensing visit combined), Post-Dispensing (after lenses were dispensed and allowed to settle) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit combined). The average grade for unique eyes with findings greater than 0 (none) is compared.</description>
        <time_frame>Change from baseline/dispensing visits, post-dispensing visit and all follow-ups visits</time_frame>
        <population>Unique eyes are defined as each individual eye in the study and are only counted once for each of the visit groupings.</population>
        <group_list>
          <group group_id="O1">
            <title>Enfilcon A</title>
            <description>The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.</description>
          </group>
          <group group_id="O2">
            <title>Galyfilcon A</title>
            <description>The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Assessment: Ocular Response - Biomicroscopy</title>
          <description>The primary safety endpoint are the objective slit lamp findings associated with the enfilcon A contact lenses compared with those same findings reported as associated with the galyfilcon A contact lenses.&#xD;
The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline/Dispensing (baseline and dispensing visit combined), Post-Dispensing (after lenses were dispensed and allowed to settle) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit combined). The average grade for unique eyes with findings greater than 0 (none) is compared.</description>
          <population>Unique eyes are defined as each individual eye in the study and are only counted once for each of the visit groupings.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>unique eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>unique eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Epithelial Edema, Baseline/Dispensing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="1" upper_limit="1"/>
                    <measurement group_id="O2" value="NA" lower_limit="0" upper_limit="0">No participants experienced greater than 0 at this time point.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Epithelial Edema, Post-Dispensing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="0" upper_limit="0">No participants experienced greater than 0 at this time point.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="0" upper_limit="0">No participants experienced greater than 0 at this time point.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Epithelial Edema, All Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="0" upper_limit="0">No participants experienced greater than 0 at this time point.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="0" upper_limit="0">No participants experienced greater than 0 at this time point.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stromal Edema, Basline/Dispensing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="0" upper_limit="0">No participants experienced greater than 0 at this time point.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="0" upper_limit="0">No participants experienced greater than 0 at this time point.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stromal Edema, Post-Dispensing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="0" upper_limit="0">No participants experienced greater than 0 at this time point.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="0" upper_limit="0">No participants experienced greater than 0 at this time point.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stromal Edema, All Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="0" upper_limit="0">No participants experienced greater than 0 at this time point.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="0" upper_limit="0">No participants experienced greater than 0 at this time point.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neovascularization, Baseline/Dispensing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="1" upper_limit="1"/>
                    <measurement group_id="O2" value="1.00" lower_limit="1" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neovascularization, Post-Dispensing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="0" upper_limit="0">No participants experienced greater than 0 at this time point.</measurement>
                    <measurement group_id="O2" value="1.00" lower_limit="1" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neovascularization, All Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="1" upper_limit="1"/>
                    <measurement group_id="O2" value="1.00" lower_limit="1" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Corneal Staining, Baseline/Dispensing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.06" lower_limit="1" upper_limit="2"/>
                    <measurement group_id="O2" value="1.08" lower_limit="1" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Corneal Staining, Post-Dispensing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="1" upper_limit="1"/>
                    <measurement group_id="O2" value="1.00" lower_limit="1" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Corneal Staining, All Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.02" lower_limit="1" upper_limit="2"/>
                    <measurement group_id="O2" value="1.04" lower_limit="1" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Limbal Hyperemia, Baseline/Dispensing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.07" lower_limit="1" upper_limit="2"/>
                    <measurement group_id="O2" value="1.00" lower_limit="1" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Limbal Hyperemia, Post-Dispensing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="1" upper_limit="1"/>
                    <measurement group_id="O2" value="1.00" lower_limit="1" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Limbal Hyperemia, All Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="1" upper_limit="1"/>
                    <measurement group_id="O2" value="1.00" lower_limit="1" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulbar Hyperemia, Baseline/Dispensing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="1" upper_limit="1"/>
                    <measurement group_id="O2" value="1.00" lower_limit="1" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulbar Hyperemia, Post-Dispensing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="1" upper_limit="1"/>
                    <measurement group_id="O2" value="1.00" lower_limit="1" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulbar Hyperemia, All Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="1" upper_limit="1"/>
                    <measurement group_id="O2" value="1.00" lower_limit="1" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Palpebral Conjunctiva, Baseline/Dispensing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.11" lower_limit="1" upper_limit="2"/>
                    <measurement group_id="O2" value="1.12" lower_limit="1" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Palpebral Conjunctiva, Post-Dispensing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="1" upper_limit="1"/>
                    <measurement group_id="O2" value="1.14" lower_limit="1" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Palpebral Conjunctiva, All Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.05" lower_limit="1" upper_limit="2"/>
                    <measurement group_id="O2" value="1.16" lower_limit="1" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Comparison of Objective Findings - Number of Adverse Events in Unique Eyes</title>
        <description>The primary safety endpoint are the objective findings of the number of adverse events in unique eyes associated with the enfilcon A contact lenses compared with those same findings as associated with the galyfilcon A contact lenses.&#xD;
The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence from Baseline through end of month 1 visit.</description>
        <time_frame>Any occurrence from baseline to 1 month visit</time_frame>
        <population>Unique eyes are defined as each individual eye in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Enfilcon A</title>
            <description>The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.</description>
          </group>
          <group group_id="O2">
            <title>Galyfilcon A</title>
            <description>The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of Objective Findings - Number of Adverse Events in Unique Eyes</title>
          <description>The primary safety endpoint are the objective findings of the number of adverse events in unique eyes associated with the enfilcon A contact lenses compared with those same findings as associated with the galyfilcon A contact lenses.&#xD;
The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence from Baseline through end of month 1 visit.</description>
          <population>Unique eyes are defined as each individual eye in the study.</population>
          <units>number of adverse events</units>
          <param>Number</param>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From dispense up to one month on both the study lenses, a total of two months.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Enfilcon A</title>
          <description>The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.</description>
        </group>
        <group group_id="E2">
          <title>Galyfilcon A</title>
          <description>The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.</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="17"/>
              </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="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Temporary Discontinuation of Lens Wear</sub_title>
                <description>Single (one subject), bilateral event reported for the control group at day 21 as temporary discontinuation lens wear of 1 day. Subject napped with lenses in place. Awoke with red eyes. Removed the lenses for the remainder of the day.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </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>Release of this data (through presentation, publication or other written or oral communication) to other than listed personnel (see protocol) requires the prior written permission from the study Sponsor. Study investigators and all office personnelare prohibited from acknowledging participation in the study to individuals and organizations except those listed.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>William J. Gleason, O.D.</name_or_title>
      <organization>Foresight Regulatory Strategies, Inc.</organization>
      <phone>(978) 658-6888 ext 151</phone>
    </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/NCT01706770
org study id: FC111216
nct id: NCT01706770
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
The primary objective of thes study is to confirm that the ocular response to the Test lenses
      are similar to those of the Control lenses when used in a 1 week planned replacement, daily
      wear modality over a 1-month period.
The test lens and control lens were randomized in a 2:1 ratio to evaluate the test lens and
      control contact lens.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Assessment: Ocular Response - Biomicroscopy
time frame: Change from baseline/dispensing visits, post-dispensing visit and all follow-ups visits
description: The primary safety endpoint are the objective slit lamp findings associated with the enfilcon A contact lenses compared with those same findings reported as associated with the galyfilcon A contact lenses.
The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline/Dispensing (baseline and dispensing visit combined), Post-Dispensing (after lenses were dispensed and allowed to settle) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit combined). The average grade for unique eyes with findings greater than 0 (none) is compared.
measure: Comparison of Objective Findings - Number of Adverse Events in Unique Eyes
time frame: Any occurrence from baseline to 1 month visit
description: The primary safety endpoint are the objective findings of the number of adverse events in unique eyes associated with the enfilcon A contact lenses compared with those same findings as associated with the galyfilcon A contact lenses.
The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence from Baseline through end of month 1 visit.
arm group label: enfilcon A
arm group type: Experimental
description: The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
arm group label: galyfilcon A
arm group type: Active Comparator
description: The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
intervention type: Device
intervention name: enfilcon A
arm group label: enfilcon A
other name: Avaira® Toric
intervention type: Device
intervention name: galyfilcon A
arm group label: galyfilcon A
other name: Acvuve® Advance®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Scott E Schachter, OD
role: Principal Investigator
affiliation: Unafiliated
last name: Cheryl Vincent-Reimer, OD
role: Principal Investigator
affiliation: Unafiliated
last name: Eric White, OD
role: Principal Investigator
affiliation: Unafiliated
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Refractive Errors
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 