<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/NCT03787472</url>
  </required_header>
  <id_info>
    <org_study_id>CR-6317</org_study_id>
    <nct_id>NCT03787472</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Manufacturing Processes for a Reusable Multifocal Optical Design in a Presbyopic Population</brief_title>
  <official_title>Clinical Evaluation of Manufacturing Curing Processes for a Reusable Multifocal Optical Design in a Presbyopic Population</official_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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The clinical study is a randomized-controlled, double-masked, crossover clinical trial with&#xD;
      two study treatments to compare two study lens types and the initial performance, in terms of&#xD;
      the subjective response after a period of lens dispensing. The study will last approximately&#xD;
      2 to 4 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 11, 2019</start_date>
  <completion_date type="Actual">March 22, 2019</completion_date>
  <primary_completion_date type="Actual">March 22, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CLUE Vision</measure>
    <time_frame>2-Week Follow-up</time_frame>
    <description>Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>logMAR Visual Acuity</measure>
    <time_frame>2-Week Follow-up</time_frame>
    <description>Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated under high luminance and high contrast conditions at three distances:&#xD;
Distance (3 meters) was measured using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; Intermediate (64 centimeters) and Near (40 centimeters) were measured using Reduced Guillon-Poling Charts.&#xD;
Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Visual Acuity</condition>
  <arm_group>
    <arm_group_label>Test/Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hyperopic subjects that are habitual soft contact lens wearers and have presbyopia will be randomized into one the sequence (Test/Control).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control/Test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hyperopic subjects that are habitual soft contact lens wearers and have presbyopia will be randomized into the sequence (Control/Test).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>JJV Investigational senofilcon A Multifocal Lens1</intervention_name>
    <description>CONTROL</description>
    <arm_group_label>Control/Test</arm_group_label>
    <arm_group_label>Test/Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>JJV Investigational senofilcon A Multifocal Lens2</intervention_name>
    <description>TEST</description>
    <arm_group_label>Control/Test</arm_group_label>
    <arm_group_label>Test/Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Potential subjects must satisfy all the following criteria to be enrolled in the&#xD;
             study:&#xD;
&#xD;
               1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and&#xD;
                  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&#xD;
                  in this clinical protocol.&#xD;
&#xD;
               3. The subject must be at least 40 years of age and not greater than 70 years of&#xD;
                  age.&#xD;
&#xD;
               4. The subject's distance spherical equivalent refraction must be in the range of&#xD;
                  +1.25 D to +3.75 D in each eye.&#xD;
&#xD;
               5. The subject's refractive cylinder must be ≤0.75 D in each eye.&#xD;
&#xD;
               6. The subject's ADD power must be in the range of +0.75 D to +2.50 D.&#xD;
&#xD;
               7. The subject must have distance best corrected visual acuity of 20/20-3 or better&#xD;
                  in each eye.&#xD;
&#xD;
               8. Subjects must own a wearable pair of spectacles if required for their distance&#xD;
                  vision.&#xD;
&#xD;
               9. The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn&#xD;
                  lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1&#xD;
                  month of more duration).&#xD;
&#xD;
              10. The subject must either already be wearing a presbyopic contact lens correction&#xD;
                  (e.g., reading spectacles over contact lenses, multifocal or monovision contact&#xD;
                  lenses, etc.) or if not respond positively to at least one symptom on the&#xD;
                  &quot;Presbyopic Symptoms Questionnaire&quot;.&#xD;
&#xD;
                  Exclusion Criteria:&#xD;
&#xD;
          -  Potential subjects who meet any of the following criteria will be excluded from&#xD;
             participating in the study:&#xD;
&#xD;
               1. Currently pregnant or lactating.&#xD;
&#xD;
               2. Any active or ongoing ocular or systemic allergies that may interfere with&#xD;
                  contact lens wear.&#xD;
&#xD;
               3. Any active or ongoing systemic disease, autoimmune disease, or use of medication,&#xD;
                  which may interfere with contact lens wear. This may include, but not be limited&#xD;
                  to, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea,&#xD;
                  Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious&#xD;
                  diseases (e.g. hepatitis, tuberculosis).&#xD;
&#xD;
               4. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization,&#xD;
                  corneal staining, tarsal abnormalities or bulbar injection, or any other corneal&#xD;
                  or ocular abnormalities which would contraindicate contact lens wear.&#xD;
&#xD;
               5. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma,&#xD;
                  history of recurrent corneal erosions.&#xD;
&#xD;
               6. Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy,&#xD;
                  PRK, LASIK, lid procedures, dacryocystorhinostomy cataract surgery, retinal&#xD;
                  surgery, etc.).&#xD;
&#xD;
               7. A history of amblyopia, strabismus or binocular vision abnormality.&#xD;
&#xD;
               8. Any current ocular infection or inflammation.&#xD;
&#xD;
               9. Any current ocular abnormality that may interfere with contact lens wear.&#xD;
&#xD;
              10. Use of any of the following oral medications within 1 week prior to enrollment:&#xD;
                  oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical&#xD;
                  scopolamine, systemic steroids.&#xD;
&#xD;
              11. Use of any ocular medication, with the exception of rewetting drops.&#xD;
&#xD;
              12. History of herpetic keratitis.&#xD;
&#xD;
              13. Participation in any contact lens or lens care product clinical trial within 30&#xD;
                  days prior to study enrollment.&#xD;
&#xD;
              14. Employee or immediate family member of an employee of clinical site (e.g.,&#xD;
                  Investigator, Coordinator, Technician).&#xD;
&#xD;
              15. Any known hypersensitivity or allergic reaction to Optifree®Replenish®&#xD;
                  multipurpose care solution, sodium fluorescein or Eye-Cept® rewetting drop&#xD;
                  solution.&#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>
      <name>Maitland Vision Center</name>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <zip>32751</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Eyecare</name>
      <address>
        <city>Raytown</city>
        <state>Missouri</state>
        <zip>64133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spectrum Eyecare</name>
      <address>
        <city>Jamestown</city>
        <state>New York</state>
        <zip>14701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Reserve Vision Care, Inc</name>
      <address>
        <city>Beachwood</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ProCare Vision Centers</name>
      <address>
        <city>Granville</city>
        <state>Ohio</state>
        <zip>43023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <results_first_submitted>May 7, 2020</results_first_submitted>
  <results_first_submitted_qc>June 10, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 23, 2020</results_first_posted>
  <disposition_first_submitted>March 16, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>June 10, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">June 23, 2020</disposition_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Johnson &amp; Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu</ipd_description>
    <ipd_url>http://yoda.yale.edu</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT03787472/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 45 subjects were enrolled in this study and all 45 subjects were randomly assigned to one of the two lens sequences and completed the study. 3 subjects were excluded from analysis and 42 were included in Per-Protocol Population.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Test/Control</title>
          <description>Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period</description>
        </group>
        <group group_id="P2">
          <title>Control/Test</title>
          <description>Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Due to the Protocol Deviation, 3 subjects were excluded from the analysis population.</population>
      <group_list>
        <group group_id="B1">
          <title>Total</title>
          <description>All subjects who had successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="42"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.1" spread="7.55"/>
                  </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="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </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="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>CLUE Vision</title>
        <description>Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.</description>
        <time_frame>2-Week Follow-up</time_frame>
        <population>All subjects who had successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.</population>
        <group_list>
          <group group_id="O1">
            <title>Test</title>
            <description>Subjects that wore the Test lens in either the first or second period of the study.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Subjects that wore the Control lens in either the first or second period of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>CLUE Vision</title>
          <description>Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.</description>
          <population>All subjects who had successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.</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="42"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.77" spread="18.872"/>
                    <measurement group_id="O2" value="52.23" spread="19.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.</non_inferiority_desc>
            <param_type>Least-Square Mean Difference</param_type>
            <param_value>0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.98</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.5</ci_lower_limit>
            <ci_upper_limit>6.6</ci_upper_limit>
            <estimate_desc>Mean difference was calculated as Test - Control</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>logMAR Visual Acuity</title>
        <description>Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated under high luminance and high contrast conditions at three distances:&#xD;
Distance (3 meters) was measured using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; Intermediate (64 centimeters) and Near (40 centimeters) were measured using Reduced Guillon-Poling Charts.&#xD;
Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.</description>
        <time_frame>2-Week Follow-up</time_frame>
        <population>All subjects who had successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.</population>
        <group_list>
          <group group_id="O1">
            <title>Test</title>
            <description>Subjects that wore the Test lens in either the first or second period of the study.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Subjects that wore the Control lens in either the first or second period of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>logMAR Visual Acuity</title>
          <description>Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated under high luminance and high contrast conditions at three distances:&#xD;
Distance (3 meters) was measured using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; Intermediate (64 centimeters) and Near (40 centimeters) were measured using Reduced Guillon-Poling Charts.&#xD;
Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.</description>
          <population>All subjects who had successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.</population>
          <units>logMAR units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Distance Standard High Contrast Bright</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.088" spread="0.0885"/>
                    <measurement group_id="O2" value="-0.096" spread="0.0938"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intermediate Standard High Contrast Bright</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.047" spread="0.0863"/>
                    <measurement group_id="O2" value="-0.035" spread="0.0950"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Near Standard High Contrast Bright</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.080" spread="0.0908"/>
                    <measurement group_id="O2" value="0.076" spread="0.0903"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Distance Standard High Contrast Bright</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.</non_inferiority_desc>
            <param_type>Least-Square Mean Difference</param_type>
            <param_value>0.008</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0166</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.025</ci_lower_limit>
            <ci_upper_limit>0.041</ci_upper_limit>
            <estimate_desc>Mean difference was calculated as Test - Control</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Intermediate Standard High Contrast Bright</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.</non_inferiority_desc>
            <param_type>Least-Square Mean Difference</param_type>
            <param_value>-0.012</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0155</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.043</ci_lower_limit>
            <ci_upper_limit>0.019</ci_upper_limit>
            <estimate_desc>Mean difference was calculated as Test - Control</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Near Standard High Contrast Bright</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.</non_inferiority_desc>
            <param_type>Least-Square Mean Difference</param_type>
            <param_value>0.003</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0169</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.030</ci_lower_limit>
            <ci_upper_limit>0.037</ci_upper_limit>
            <estimate_desc>Mean difference was calculated as Test - Control</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Throughout the duration of the study. Approximately 5 weeks per subject.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Test</title>
          <description>Subjects that wore the Test lens in either the first or second period of the study.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Subjects that wore the Control lens in 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, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
              </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="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
              </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, OD, MS, FAAO- Sr. Principal Research Optometrist</name_or_title>
      <organization>Johnson &amp; Johnson Vision Care</organization>
      <phone>904-443-3402</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/NCT03787472
org study id: CR-6317
nct id: NCT03787472
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The clinical study is a randomized-controlled, double-masked, crossover clinical trial with
      two study treatments to compare two study lens types and the initial performance, in terms of
      the subjective response after a period of lens dispensing. The study will last approximately
      2 to 4 months.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: CLUE Vision
time frame: 2-Week Follow-up
description: Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
measure: logMAR Visual Acuity
time frame: 2-Week Follow-up
description: Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated under high luminance and high contrast conditions at three distances:
Distance (3 meters) was measured using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; Intermediate (64 centimeters) and Near (40 centimeters) were measured using Reduced Guillon-Poling Charts.
Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
arm group label: Test/Control
arm group type: Experimental
description: Hyperopic subjects that are habitual soft contact lens wearers and have presbyopia will be randomized into one the sequence (Test/Control).
arm group label: Control/Test
arm group type: Experimental
description: Hyperopic subjects that are habitual soft contact lens wearers and have presbyopia will be randomized into the sequence (Control/Test).
intervention type: Device
intervention name: JJV Investigational senofilcon A Multifocal Lens1
description: CONTROL
arm group label: Control/Test
arm group label: Test/Control
intervention type: Device
intervention name: JJV Investigational senofilcon A Multifocal Lens2
description: TEST
arm group label: Control/Test
arm group label: Test/Control
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
ipd url: http://yoda.yale.edu
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 