<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/NCT02223754</url>
  </required_header>
  <id_info>
    <org_study_id>CR-5593</org_study_id>
    <nct_id>NCT02223754</nct_id>
  </id_info>
  <brief_title>Evaluation of an Investigational Multifocal Lens</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johnson &amp; Johnson Vision Care, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johnson &amp; Johnson Vision Care, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the performance of an investigational multifocal test&#xD;
      soft contact lens.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire</measure>
    <time_frame>8 -12 days post wear</time_frame>
    <description>CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distance Binocular Visual Acuity (LogMAR)</measure>
    <time_frame>8- 12 Days post wear</time_frame>
    <description>Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intermediate Binocular Visual Acuity (LogMAR)</measure>
    <time_frame>8-12 days post wear</time_frame>
    <description>Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Near Binocular Visual Acuity (LogMAR)</measure>
    <time_frame>8-12 days post wear</time_frame>
    <description>Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Corneal Staining</measure>
    <time_frame>8 - 12 Days post wear</time_frame>
    <description>Corneal staining is evaluated using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bulbar Conjunctival Injection</measure>
    <time_frame>8- 12 Days post wear</time_frame>
    <description>The bulbar is the scelra. Bulbar Conjunctival Injection was assessed using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Limbal Conjunctival Injection</measure>
    <time_frame>8- 12 Days post wear</time_frame>
    <description>The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjunctival Injection was assesed using the Efron grading scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Contact Lens Fitting</measure>
    <time_frame>8- 12 Days post wear</time_frame>
    <description>Contact Lens fitting is reported as a binary response. Yes- acceptable lens fit, No- unacceptable lens fit. The percentage of subject eyes with acceptable fit is reported.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">371</enrollment>
  <condition>Presbyopia</condition>
  <arm_group>
    <arm_group_label>lotrafilcon B / etafilcon A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subject randomized to this sequence will first be dispensed the lotrafilcon B contact lens and then the etafilcon A contact lens.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>etafilcon A / lotrafilcon B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject randomized to this sequence will first be dispensed the etafilcon A contact lens and then the lotrafilcon B contact lens.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>lotrafilcon B</intervention_name>
    <description>Soft contact lens to be worn as daily wear, monthly replacement modality.</description>
    <arm_group_label>etafilcon A / lotrafilcon B</arm_group_label>
    <arm_group_label>lotrafilcon B / etafilcon A</arm_group_label>
    <other_name>AirOptix Aqua Multifocal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>etafilcon A</intervention_name>
    <description>Soft contact lens to be worn as daily wear, daily disposable modality.</description>
    <arm_group_label>etafilcon A / lotrafilcon B</arm_group_label>
    <arm_group_label>lotrafilcon B / etafilcon A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subjects were required to have read, understand, and signed the Statement of&#xD;
             Informed Consent and receive a fully executed copy of the form.&#xD;
&#xD;
          2. The subject must appear able and willing to adhere to the instructions set forth in&#xD;
             this clinical protocol.&#xD;
&#xD;
          3. Between 40 and 70 years of age.&#xD;
&#xD;
          4. Subjects must own a wearable pair of spectacles, if required for their distance&#xD;
             vision.&#xD;
&#xD;
          5. Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2&#xD;
             days per week for at least 8 hours per wear day, for 1 month of more duration)&#xD;
&#xD;
          6. Already be wearing a presbyopic contact lens correction (e.g., reading spectacles over&#xD;
             contact lenses, multifocal or monovision contact lenses, etc.) or if not respond&#xD;
             positively to at least one symptom on the &quot;Presbyopic Symptoms Questionnaire&quot;*&#xD;
&#xD;
          7. The subject's vertex corrected spherical equivalent distance refraction was required&#xD;
             to be in the range +3.50 to -5.75 in each eye.&#xD;
&#xD;
          8. Refractive cylinder ≤ -0.75 D in each eye.&#xD;
&#xD;
          9. ADD power in the range +0.75 D to +2.50 D in each eye.&#xD;
&#xD;
         10. Best corrected visual acuity of 20/20-3 or better in each eye.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Currently pregnant or lactating (subjects who became pregnant during the study were&#xD;
             discontinued).&#xD;
&#xD;
          2. Any ocular or systemic allergies that may have contraindicated contact lens wear.&#xD;
&#xD;
          3. Any ocular or systemic disease, autoimmune disease, or use of medication, that may&#xD;
             have contraindicated contact lens wear.&#xD;
&#xD;
          4. Any ocular abnormality that may have interfered with contact lens wear.&#xD;
&#xD;
          5. Use of any ocular medication, with the exception of rewetting drops.&#xD;
&#xD;
          6. Any previous intraocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).&#xD;
&#xD;
          7. History of herpetic keratitis.&#xD;
&#xD;
          8. History of binocular vision abnormality or strabismus.&#xD;
&#xD;
          9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious&#xD;
             immunosuppressive disease (e.g., HIV).&#xD;
&#xD;
         10. History of diabetes.&#xD;
&#xD;
         11. Participation in any contact lens or lens care product clinical trial within 30 days&#xD;
             prior to study enrollment.&#xD;
&#xD;
         12. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization,&#xD;
             corneal staining, tarsal abnormalities, conjunctival injection) which may&#xD;
             contraindicate contact lens wear.&#xD;
&#xD;
         13. Any ocular infection or inflammation.&#xD;
&#xD;
         14. Any corneal distortion or irregular cornea.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Montgomery</city>
        <state>Alabama</state>
        <zip>36109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mission Viejo</city>
        <state>California</state>
        <zip>92691</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32250</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orange Park</city>
        <state>Florida</state>
        <zip>32065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Augustine</city>
        <state>Florida</state>
        <zip>32092</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33625</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Winter Park</city>
        <state>Florida</state>
        <zip>32792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Roswell</city>
        <state>Georgia</state>
        <zip>30076</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pittsburg</city>
        <state>Kansas</state>
        <zip>66762</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>East Lansing</city>
        <state>Michigan</state>
        <zip>48823</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vestal</city>
        <state>New York</state>
        <zip>13850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Denver</city>
        <state>North Carolina</state>
        <zip>28037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Powell</city>
        <state>Ohio</state>
        <zip>43065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Springfield</city>
        <state>Ohio</state>
        <zip>45503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02888</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salem</city>
        <state>Virginia</state>
        <zip>24153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <results_first_submitted>June 8, 2016</results_first_submitted>
  <results_first_submitted_qc>July 18, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 31, 2016</results_first_posted>
  <last_update_submitted>June 18, 2018</last_update_submitted>
  <last_update_submitted_qc>June 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2018</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>Presbyopia</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>This study enrolled a total of 371 subjects. Of those enrolled subjects 49 did not meet the eligibility criteria and 322 subjects were dispensed a study lens. Of the dispensed subjects 297 completed the study and 25 were discontinued from the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Etafilcon A / Lotrafilcon B</title>
          <description>Subjects were randomized to one of two lens sequences. Subjects first received the etafilcon A contact lens and then received the Control lens (lotrafilcon B contact lens.</description>
        </group>
        <group group_id="P2">
          <title>Lotrafilcon B/ Etafilcon A</title>
          <description>Subjects were randomized to one of two lens sequences. Subjects first received the lotrafilcon B lens and then received the etafilcon A lens.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="163"/>
                <participants group_id="P2" count="159"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="159"/>
                <participants group_id="P2" count="144"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Test Article No Longer Available</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unsatisfactory Visual Response</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="159"/>
                <participants group_id="P2" count="144"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="156"/>
                <participants group_id="P2" count="141"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lens Discomfort</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <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>Test Article No Longer Available</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The analysis population consists of subjects that were dispensed a study lens.</population>
      <group_list>
        <group group_id="B1">
          <title>Etafilcon A / Lotrafilcon B</title>
          <description>Subjects that were randomized to this sequence and were dispensed a study lens.</description>
        </group>
        <group group_id="B2">
          <title>Lotrafilcon B / Etafilcon A</title>
          <description>Subjects that were randomized to this sequence and were dispensed a study lens.</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="163"/>
            <count group_id="B2" value="159"/>
            <count group_id="B3" value="322"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Hyperopes, N=59, N=53, N=112</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.3" spread="6.59"/>
                    <measurement group_id="B2" value="51.9" spread="7.04"/>
                    <measurement group_id="B3" value="52.1" spread="6.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myopes, N=104, N=106, N=210</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.3" spread="6.10"/>
                    <measurement group_id="B2" value="49.5" spread="5.77"/>
                    <measurement group_id="B3" value="49.4" spread="5.92"/>
                  </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="128"/>
                    <measurement group_id="B2" value="120"/>
                    <measurement group_id="B3" value="248"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="25"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="147"/>
                    <measurement group_id="B2" value="144"/>
                    <measurement group_id="B3" value="291"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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="163"/>
                    <measurement group_id="B2" value="159"/>
                    <measurement group_id="B3" value="322"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire</title>
        <description>CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).</description>
        <time_frame>8 -12 days post wear</time_frame>
        <population>The analysis population consists of subjects that completed all study visits without a major protocol deviation.</population>
        <group_list>
          <group group_id="O1">
            <title>Etafilcon A</title>
            <description>Subjects that received the etafilcon A contact lens during either the first or second period of the study.</description>
          </group>
          <group group_id="O2">
            <title>Lotrafilcon B</title>
            <description>Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire</title>
          <description>CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).</description>
          <population>The analysis population consists of subjects that completed all study visits without a major protocol deviation.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="275"/>
                <count group_id="O2" value="275"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hyperopes, N=94, N=94</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.15" spread="21.647"/>
                    <measurement group_id="O2" value="54.28" spread="20.749"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myopes, N=181, N=181</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.55" spread="18.644"/>
                    <measurement group_id="O2" value="51.84" spread="19.319"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Distance Binocular Visual Acuity (LogMAR)</title>
        <description>Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast.</description>
        <time_frame>8- 12 Days post wear</time_frame>
        <population>The analysis population consists of subjects that have completed all study visits without a major protocol deviation.</population>
        <group_list>
          <group group_id="O1">
            <title>Etafilcon A</title>
            <description>Subjects that received the etafilcon A contact lens during either the first or second period of the study.</description>
          </group>
          <group group_id="O2">
            <title>Lotrafilcon B</title>
            <description>Subjects that received the lotrafilcon B during either the first or second period of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Distance Binocular Visual Acuity (LogMAR)</title>
          <description>Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast.</description>
          <population>The analysis population consists of subjects that have completed all study visits without a major protocol deviation.</population>
          <units>LogMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="275"/>
                <count group_id="O2" value="275"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hyperopes, N=94, N=94</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.069" spread="0.0908"/>
                    <measurement group_id="O2" value="-0.066" spread="0.0982"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myopes, N=180, N=181</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.100" spread="0.0991"/>
                    <measurement group_id="O2" value="-0.093" spread="0.0981"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Intermediate Binocular Visual Acuity (LogMAR)</title>
        <description>Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.</description>
        <time_frame>8-12 days post wear</time_frame>
        <population>The analysis population consists of subjects that completed all study visits without a major protocol deviation.</population>
        <group_list>
          <group group_id="O1">
            <title>Etafilcon A</title>
            <description>Subjects that received the etafilcon A contact lens during either the first or second period of the study.</description>
          </group>
          <group group_id="O2">
            <title>Lotrafilcon B</title>
            <description>Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Intermediate Binocular Visual Acuity (LogMAR)</title>
          <description>Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.</description>
          <population>The analysis population consists of subjects that completed all study visits without a major protocol deviation.</population>
          <units>LogMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="275"/>
                <count group_id="O2" value="275"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hyperopes, N=94, N=94</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.061" spread="0.0829"/>
                    <measurement group_id="O2" value="-0.050" spread="0.0897"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myopes, N=180, N=181</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.081" spread="0.0803"/>
                    <measurement group_id="O2" value="-0.063" spread="0.0894"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Near Binocular Visual Acuity (LogMAR)</title>
        <description>Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.</description>
        <time_frame>8-12 days post wear</time_frame>
        <population>The analysis population consists of subjects that completed all study visits without a major protocol deviation.</population>
        <group_list>
          <group group_id="O1">
            <title>Etafilcon A</title>
            <description>Subjects that received the etafilcon A contact lens during either the first or second period of the study.</description>
          </group>
          <group group_id="O2">
            <title>Lotrafilcon B</title>
            <description>Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Near Binocular Visual Acuity (LogMAR)</title>
          <description>Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.</description>
          <population>The analysis population consists of subjects that completed all study visits without a major protocol deviation.</population>
          <units>LogMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="275"/>
                <count group_id="O2" value="275"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hyperopes, N=94, N=94</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.050" spread="0.0970"/>
                    <measurement group_id="O2" value="0.074" spread="0.1035"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myopes, N=180, N=181</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.034" spread="0.1039"/>
                    <measurement group_id="O2" value="0.049" spread="0.1176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Corneal Staining</title>
        <description>Corneal staining is evaluated using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.</description>
        <time_frame>8 - 12 Days post wear</time_frame>
        <population>The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.</population>
        <group_list>
          <group group_id="O1">
            <title>Etafilcon A</title>
            <description>Subjects that received the etafilcon A contact lens during either the first or second period of the study.</description>
          </group>
          <group group_id="O2">
            <title>Lotrafilcon B</title>
            <description>Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Corneal Staining</title>
          <description>Corneal staining is evaluated using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.</description>
          <population>The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.</population>
          <units>percentage of Subject Eyes</units>
          <param>Number</param>
          <units_analyzed>Subject Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="275"/>
                <count group_id="O2" value="275"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Subject Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="550"/>
                <count group_id="O2" value="550"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hyperopes, N=188, N=188</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myopes, N=362, N=362</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Bulbar Conjunctival Injection</title>
        <description>The bulbar is the scelra. Bulbar Conjunctival Injection was assessed using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.</description>
        <time_frame>8- 12 Days post wear</time_frame>
        <population>The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.</population>
        <group_list>
          <group group_id="O1">
            <title>Etafilcon A</title>
            <description>Subjects that received the etafilcon A contact lens during either the first or second period of the study.</description>
          </group>
          <group group_id="O2">
            <title>Lotrafilcon B</title>
            <description>Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Bulbar Conjunctival Injection</title>
          <description>The bulbar is the scelra. Bulbar Conjunctival Injection was assessed using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.</description>
          <population>The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.</population>
          <units>Percentage of Subject Eyes</units>
          <param>Number</param>
          <units_analyzed>Subject Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="275"/>
                <count group_id="O2" value="275"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Subject Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="550"/>
                <count group_id="O2" value="550"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hyperopes, N=188, N=188</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myopes, N=362 , N=362</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Limbal Conjunctival Injection</title>
        <description>The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjunctival Injection was assesed using the Efron grading scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.</description>
        <time_frame>8- 12 Days post wear</time_frame>
        <population>The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.</population>
        <group_list>
          <group group_id="O1">
            <title>Etafilcon A</title>
            <description>Subjects that received the etafilcon A contact lens during either the first or second period of the study.</description>
          </group>
          <group group_id="O2">
            <title>Lotrafilcon B</title>
            <description>Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Limbal Conjunctival Injection</title>
          <description>The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjunctival Injection was assesed using the Efron grading scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.</description>
          <population>The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.</population>
          <units>Percentage of Subject Eyes</units>
          <param>Number</param>
          <units_analyzed>Subject Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="275"/>
                <count group_id="O2" value="275"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Subject Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="550"/>
                <count group_id="O2" value="550"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hyperopes, N=188, N=188</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myopes, N=362, N=362</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Contact Lens Fitting</title>
        <description>Contact Lens fitting is reported as a binary response. Yes- acceptable lens fit, No- unacceptable lens fit. The percentage of subject eyes with acceptable fit is reported.</description>
        <time_frame>8- 12 Days post wear</time_frame>
        <population>The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.</population>
        <group_list>
          <group group_id="O1">
            <title>Etafilcon A</title>
            <description>Subjects that received the etafilcon A contact lens during either the first or second period of the study.</description>
          </group>
          <group group_id="O2">
            <title>Lotrafilcon B</title>
            <description>Subjects that received the lotrafilcon B during either the first or second period of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Contact Lens Fitting</title>
          <description>Contact Lens fitting is reported as a binary response. Yes- acceptable lens fit, No- unacceptable lens fit. The percentage of subject eyes with acceptable fit is reported.</description>
          <population>The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.</population>
          <units>Percentage of Subject Eyes</units>
          <param>Number</param>
          <units_analyzed>Subject Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="275"/>
                <count group_id="O2" value="275"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Subject Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="550"/>
                <count group_id="O2" value="550"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hyperopes, N=188, N=188</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myopes, N=362, N=362</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.5"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Approximately 8-12 days per intervention.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Etafilcon A</title>
          <description>Subjects that received the etafilcon A contact lens during either the first or second period of the study.</description>
        </group>
        <group group_id="E2">
          <title>Lotrafilcon B</title>
          <description>Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </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="307"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="318"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Thomas R. Karkkainen, O.D., M.S., F.A.A.O., Sr. Principal Research Optemtrist</name_or_title>
      <organization>Johnson &amp; Johnson Vision Care Inc.</organization>
      <phone>904-443-3500 ext 3402</phone>
      <email>TKarkkai@its.jnj.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/NCT02223754
org study id: CR-5593
nct id: NCT02223754
lead sponsor: 
has dmc: No
The purpose of this study is to test the performance of an investigational multifocal test
      soft contact lens.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire
time frame: 8 -12 days post wear
description: CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
measure: Distance Binocular Visual Acuity (LogMAR)
time frame: 8- 12 Days post wear
description: Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast.
measure: Intermediate Binocular Visual Acuity (LogMAR)
time frame: 8-12 days post wear
description: Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
measure: Near Binocular Visual Acuity (LogMAR)
time frame: 8-12 days post wear
description: Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
measure: Corneal Staining
time frame: 8 - 12 Days post wear
description: Corneal staining is evaluated using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
measure: Bulbar Conjunctival Injection
time frame: 8- 12 Days post wear
description: The bulbar is the scelra. Bulbar Conjunctival Injection was assessed using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
measure: Limbal Conjunctival Injection
time frame: 8- 12 Days post wear
description: The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjunctival Injection was assesed using the Efron grading scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
measure: Contact Lens Fitting
time frame: 8- 12 Days post wear
description: Contact Lens fitting is reported as a binary response. Yes- acceptable lens fit, No- unacceptable lens fit. The percentage of subject eyes with acceptable fit is reported.
arm group label: lotrafilcon B / etafilcon A
arm group type: Active Comparator
description: Subject randomized to this sequence will first be dispensed the lotrafilcon B contact lens and then the etafilcon A contact lens.
arm group label: etafilcon A / lotrafilcon B
arm group type: Experimental
description: Subject randomized to this sequence will first be dispensed the etafilcon A contact lens and then the lotrafilcon B contact lens.
intervention type: Device
intervention name: lotrafilcon B
description: Soft contact lens to be worn as daily wear, monthly replacement modality.
arm group label: etafilcon A / lotrafilcon B
arm group label: lotrafilcon B / etafilcon A
other name: AirOptix Aqua Multifocal
intervention type: Device
intervention name: etafilcon A
description: Soft contact lens to be worn as daily wear, daily disposable modality.
arm group label: etafilcon A / lotrafilcon B
arm group label: lotrafilcon B / etafilcon A
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
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country: United States
responsible party type: Sponsor
mesh term: Presbyopia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 