<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/NCT02982018</url>
  </required_header>
  <id_info>
    <org_study_id>CR-5638</org_study_id>
    <nct_id>NCT02982018</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Approved and Investigational Contact Lenses Using New UV Additive</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>
    <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>
      Randomized, 8-visit dispensing study over 14 weeks to evaluate the safety and efficacy of an&#xD;
      investigational contact lens with a new UV blocker compared to a marketed contact lens.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Actual">February 18, 2017</completion_date>
  <primary_completion_date type="Actual">February 18, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Eyestrain Related to Glare</measure>
    <time_frame>Up to 12-Week Follow-up</time_frame>
    <description>Eyestrain related to glare was assessed at the 2-, 4-, 8- and 12- week follow-up visits using an 11-item questionnaire. This questionnaire assesses patient-experience attributes of soft contact lenses. Derived eyestrain related to glare scores using Item Response Theory (IRT) follow a normal distribution with a mean of 50 and a standard deviation of 10. Scores in this study ranged from 30 to 70. Lower scores indicate better performance. This questionnaire is still under development and the data collected is considered exploratory.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distance Monocular logMAR Visual Acuity (VA)</measure>
    <time_frame>Up to 12-Week Follow-up</time_frame>
    <description>Distance logMAR Visual Acuity was assessed for each subject and eye at 2-, 4- 8- and 12-weeks. The average logMAR visual acuity for each lens and time point was reported. Lower values of logMAR indicate better vision.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Eyes With Grade 3 or Higher Slit Lamp Findings</measure>
    <time_frame>Up to 12-Week Follow-up</time_frame>
    <description>Slit lamp findings were graded using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced. Measurements were taken in each subject eye at the initial visit, 2-4-8- and 12-week follow-ups. A new response variable was derived by dichotomizing the data as follows: 1 if a Grade 3or higher SLF was observed and 0 otherwise. The Percentage of eyes with Grade 3 or higher SLFs was reported for each lens and time point.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Contact Lens Wearing Time</measure>
    <time_frame>Up to 12-Week Follow-up</time_frame>
    <description>Contact lens wearing time (hours) was self-reported by each subject at the 2-, 4-, 8- and 12-week follow-ups. The average contact lens wearing time (hours) for each lens and time point was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Eyes With Subject Reported Symptoms Problems or Complaints</measure>
    <time_frame>Up to 12-Week Follow-up</time_frame>
    <description>Symptoms, problems and complaints are subject reported and were collected for each subject eye at the 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data is reported as a binary outcome of yes if a subject experience a problem or complaint or no otherwise. Symptoms, problems and complaints include the following: Burning/Stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision and Other The Percentage of subjects eyes with symptoms, problems or complaints was reported for each lens and time point.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">133</enrollment>
  <condition>Visual Acuity</condition>
  <arm_group>
    <arm_group_label>Investigational Contact Lens with UV Blocker</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be dispensed the investigational contact lens with UV blocker to wear daily for a period of 12 weeks with follow-up visits occurring after 1, 2, 4, 8, and 12 weeks. Afterwards, the subjects will wear their habitual contact lenses for a period of two weeks with weekly visits.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Marketed Contact Lens</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will be dispensed the marketed contact lens to wear daily for a period of 12 weeks with follow-up visits occurring after 1, 2, 4, 8, and 12 weeks. Afterwards, the subjects will wear their habitual contact lenses for a period of two weeks with weekly visits.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>senofilcon A with new UV blocker</intervention_name>
    <description>Investigational Contact Lens</description>
    <arm_group_label>Investigational Contact Lens with UV Blocker</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>senofilcon A</intervention_name>
    <description>J&amp;J Marketed Contact Lens</description>
    <arm_group_label>Marketed Contact Lens</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subject must read and sign the Informed Consent 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. Healthy adult males or females age ≥ 18 years of age with signed informed consent.&#xD;
             Eligible presbyopes will be those that wear full distance contact lenses in both eyes,&#xD;
             then wear reading glasses over them.&#xD;
&#xD;
          4. The subject's optimal vertexed spherical equivalent distance correction must be&#xD;
             between -1.00 and - 6.00 Diopters (D).&#xD;
&#xD;
          5. The subject's refractive cylinder must be ≤ 1.00 D in each eye.&#xD;
&#xD;
          6. The subject must have visual acuity best correctable to 20/25+3 or better for each&#xD;
             eye.&#xD;
&#xD;
          7. Subjects should own a wearable pair of spectacles.&#xD;
&#xD;
          8. The subject is a current spherical soft contact lens wearer (defined as a minimum of 6&#xD;
             hours of Daily Wear per day, at least 5 days per week, for a minimum of 1 month prior&#xD;
             to the study) and willing to wear the study lenses on a similar basis.&#xD;
&#xD;
          9. Subjects must be able and willing to wear the study lenses at least 6 hours a day, a&#xD;
             minimum of 5 days per week.&#xD;
&#xD;
         10. The subject must have normal eyes (i.e., no ocular medications or infections of any&#xD;
             type).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Currently pregnant or lactating (subjects who become pregnant during the study will be&#xD;
             discontinued).&#xD;
&#xD;
          2. Any systemic disease, autoimmune disease, or use of medication, which may interfere&#xD;
             with contact lens wear. This may include, but not be limited to, diabetes,&#xD;
             hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia,&#xD;
             acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any&#xD;
             infectious diseases (e.g. hepatitis, tuberculosis).&#xD;
&#xD;
          3. Use of any of the following medications within 1 week prior to enrollment: oral&#xD;
             retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral&#xD;
             (e.g. Seldane, Chlor-Trimeton, and Benadryl) and ophthalmic antihistamines, oral&#xD;
             phenothiazines (e.g., Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), oral&#xD;
             and ophthalmic Beta-adrenergic blockers (e.g., Propranolol, Timolol, and Practolol),&#xD;
             systemic steroids, and any prescribed or over the counter (OTC) ocular medication.&#xD;
&#xD;
          4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of&#xD;
             recurrent corneal erosions, aphakia, or moderate or above corneal distortion by&#xD;
             keratometry.&#xD;
&#xD;
          5. Any previous, or planned, ocular or interocular surgery (e.g.., radial keratotomy,&#xD;
             photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK),&#xD;
             etc.).&#xD;
&#xD;
          6. Any grade 2 or greater slit lamp findings (e.g.., edema, corneal neovascularization,&#xD;
             corneal staining, tarsal abnormalities, conjunctival injection) on the FDA&#xD;
             classification scale, any previous history or signs of a contact lens-related corneal&#xD;
             inflammatory event (e.g.., past peripheral ulcer or round peripheral scar), or any&#xD;
             other ocular abnormality that may contraindicate contact lens wear.&#xD;
&#xD;
          7. Any known hypersensitivity or allergic reaction to Optifree®Puremoist® multi-purpose&#xD;
             care solution or Eye-Cept® rewetting drop solution.&#xD;
&#xD;
          8. Any ocular infection, allergy or clinically significant ocular disease (e.g. corneal&#xD;
             edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension), or ocular&#xD;
             conditions (e.g. strabismus), which might interfere with the study.&#xD;
&#xD;
          9. Any corneal distortion resulting from previous hard or rigid gas permeable contact&#xD;
             lens wear.&#xD;
&#xD;
         10. Toric, extended wear, monovision or multi-focal contact lens correction.&#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. History of binocular vision abnormality or strabismus.&#xD;
&#xD;
         13. Employee or relative of employees of sponsor or investigational clinic (e.g.,&#xD;
             Investigator, Coordinator, Technician).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Longwood</city>
        <state>Florida</state>
        <zip>32779</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Closter</city>
        <state>New Jersey</state>
        <zip>07624</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>Pickens</city>
        <state>South Carolina</state>
        <zip>29671</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>October 31, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <results_first_submitted>May 7, 2018</results_first_submitted>
  <results_first_submitted_qc>July 18, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">July 19, 2018</results_first_posted>
  <disposition_first_submitted>December 7, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>December 22, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 19, 2018</disposition_first_posted>
  <last_update_submitted>July 18, 2018</last_update_submitted>
  <last_update_submitted_qc>July 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 16, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT02982018/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 13, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT02982018/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 133 subjects were enrolled into the study. Of the enrolled subjects 131 were dispensed study lenses and 2 subjects failed to meet the eligibility criteria. Of the dispensed subjects 123 completed the study and 8 subjects were discontinued.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Senofilcon A With New UV Blocker</title>
          <description>Subjects that wore the senofilcon A with new UV blocker lens throughout the entire duration of the study.</description>
        </group>
        <group group_id="P2">
          <title>Senofilcon A</title>
          <description>Subjects that wore the senofilcon A lens throughout the entire duration of the study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
                <participants group_id="P2" count="64"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
                <participants group_id="P2" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Incorrect Lens Dispensed</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lens Discomfort</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </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="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All subjects that were dispensed a study lens.</population>
      <group_list>
        <group group_id="B1">
          <title>Senofilcon A With New UV Blocker</title>
          <description>Subjects that wore the senofilcon A with new UV blocker lens throughout the entire duration of the study.</description>
        </group>
        <group group_id="B2">
          <title>Senofilcon A</title>
          <description>Subjects that wore the senofilcon A lens throughout the entire duration of the study.</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="67"/>
            <count group_id="B2" value="64"/>
            <count group_id="B3" value="131"/>
          </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="31.2" spread="8.15"/>
                    <measurement group_id="B2" value="32.1" spread="7.99"/>
                    <measurement group_id="B3" value="31.6" spread="8.02"/>
                  </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="45"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="92"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="39"/>
                  </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>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Eyestrain Related to Glare</title>
        <description>Eyestrain related to glare was assessed at the 2-, 4-, 8- and 12- week follow-up visits using an 11-item questionnaire. This questionnaire assesses patient-experience attributes of soft contact lenses. Derived eyestrain related to glare scores using Item Response Theory (IRT) follow a normal distribution with a mean of 50 and a standard deviation of 10. Scores in this study ranged from 30 to 70. Lower scores indicate better performance. This questionnaire is still under development and the data collected is considered exploratory.</description>
        <time_frame>Up to 12-Week Follow-up</time_frame>
        <population>Subjects that completed all study visits without a major protocol deviation.</population>
        <group_list>
          <group group_id="O1">
            <title>Senofilcon A With New UV Blocker (Test)</title>
            <description>Subjects that wore the senofilcon A with new UV blocker lens for the first 12-weeks of the study.</description>
          </group>
          <group group_id="O2">
            <title>Senofilcon A (Control)</title>
            <description>Subjects that wore the senofilcon A lens for the first 12 weeks of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Eyestrain Related to Glare</title>
          <description>Eyestrain related to glare was assessed at the 2-, 4-, 8- and 12- week follow-up visits using an 11-item questionnaire. This questionnaire assesses patient-experience attributes of soft contact lenses. Derived eyestrain related to glare scores using Item Response Theory (IRT) follow a normal distribution with a mean of 50 and a standard deviation of 10. Scores in this study ranged from 30 to 70. Lower scores indicate better performance. This questionnaire is still under development and the data collected is considered exploratory.</description>
          <population>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="61"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.64" spread="6.562"/>
                    <measurement group_id="O2" value="45.37" spread="7.631"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.40" spread="7.489"/>
                    <measurement group_id="O2" value="44.59" spread="7.300"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.67" spread="6.751"/>
                    <measurement group_id="O2" value="43.57" spread="6.012"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.66" spread="5.921"/>
                    <measurement group_id="O2" value="44.02" spread="7.687"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Distance Monocular logMAR Visual Acuity (VA)</title>
        <description>Distance logMAR Visual Acuity was assessed for each subject and eye at 2-, 4- 8- and 12-weeks. The average logMAR visual acuity for each lens and time point was reported. Lower values of logMAR indicate better vision.</description>
        <time_frame>Up to 12-Week Follow-up</time_frame>
        <population>Subjects that completed all study visits without a major protocol deviation.</population>
        <group_list>
          <group group_id="O1">
            <title>Senofilcon A With New UV Blocker (Test)</title>
            <description>Subjects that wore the senofilcon A with new UV blocker lens for the first 12-weeks of the study.</description>
          </group>
          <group group_id="O2">
            <title>Senofilcon A (Control)</title>
            <description>Subjects that wore the senofilcon A lens for the first 12 weeks of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Distance Monocular logMAR Visual Acuity (VA)</title>
          <description>Distance logMAR Visual Acuity was assessed for each subject and eye at 2-, 4- 8- and 12-weeks. The average logMAR visual acuity for each lens and time point was reported. Lower values of logMAR indicate better vision.</description>
          <population>Subjects that completed all study visits without a major protocol deviation.</population>
          <units>logMAR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="122"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.107" spread="0.0673"/>
                    <measurement group_id="O2" value="-0.080" spread="0.0663"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.106" spread="0.0713"/>
                    <measurement group_id="O2" value="-0.091" spread="0.0678"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.115" spread="0.0776"/>
                    <measurement group_id="O2" value="-0.0881" spread="0.0665"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.105" spread="0.0769"/>
                    <measurement group_id="O2" value="-0.0892" spread="0.0686"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Eyes With Grade 3 or Higher Slit Lamp Findings</title>
        <description>Slit lamp findings were graded using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced. Measurements were taken in each subject eye at the initial visit, 2-4-8- and 12-week follow-ups. A new response variable was derived by dichotomizing the data as follows: 1 if a Grade 3or higher SLF was observed and 0 otherwise. The Percentage of eyes with Grade 3 or higher SLFs was reported for each lens and time point.</description>
        <time_frame>Up to 12-Week Follow-up</time_frame>
        <population>All subjects that were dispensed at least one study lens.</population>
        <group_list>
          <group group_id="O1">
            <title>Senofilcon A With New UV Blocker (Test)</title>
            <description>Subjects that wore the senofilcon A with new UV blocker lens for the first 12-weeks of the study.</description>
          </group>
          <group group_id="O2">
            <title>Senofilcon A (Control)</title>
            <description>Subjects that wore the senofilcon A lens for the first 12 weeks of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eyes With Grade 3 or Higher Slit Lamp Findings</title>
          <description>Slit lamp findings were graded using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced. Measurements were taken in each subject eye at the initial visit, 2-4-8- and 12-week follow-ups. A new response variable was derived by dichotomizing the data as follows: 1 if a Grade 3or higher SLF was observed and 0 otherwise. The Percentage of eyes with Grade 3 or higher SLFs was reported for each lens and time point.</description>
          <population>All subjects that were dispensed at least one study lens.</population>
          <units>Percentage of eyes</units>
          <param>Number</param>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="134"/>
                <count group_id="O2" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Contact Lens Wearing Time</title>
        <description>Contact lens wearing time (hours) was self-reported by each subject at the 2-, 4-, 8- and 12-week follow-ups. The average contact lens wearing time (hours) for each lens and time point was reported.</description>
        <time_frame>Up to 12-Week Follow-up</time_frame>
        <population>Subjects that completed all study visits without a major protocol deviation.</population>
        <group_list>
          <group group_id="O1">
            <title>Senofilcon A With New UV Blocker (Test)</title>
            <description>Subjects that wore the senofilcon A with new UV blocker lens for the first 12-weeks of the study.</description>
          </group>
          <group group_id="O2">
            <title>Senofilcon A (Control)</title>
            <description>Subjects that wore the senofilcon A lens for the first 12 weeks of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Contact Lens Wearing Time</title>
          <description>Contact lens wearing time (hours) was self-reported by each subject at the 2-, 4-, 8- and 12-week follow-ups. The average contact lens wearing time (hours) for each lens and time point was reported.</description>
          <population>Subjects that completed all study visits without a major protocol deviation.</population>
          <units>Hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.7" spread="1.76"/>
                    <measurement group_id="O2" value="14.0" spread="2.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.5" spread="2.03"/>
                    <measurement group_id="O2" value="14.2" spread="2.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.6" spread="1.78"/>
                    <measurement group_id="O2" value="14.1" spread="2.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.7" spread="1.67"/>
                    <measurement group_id="O2" value="14.3" spread="1.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Eyes With Subject Reported Symptoms Problems or Complaints</title>
        <description>Symptoms, problems and complaints are subject reported and were collected for each subject eye at the 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data is reported as a binary outcome of yes if a subject experience a problem or complaint or no otherwise. Symptoms, problems and complaints include the following: Burning/Stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision and Other The Percentage of subjects eyes with symptoms, problems or complaints was reported for each lens and time point.</description>
        <time_frame>Up to 12-Week Follow-up</time_frame>
        <population>All subjects that were dispensed at least one study lens.</population>
        <group_list>
          <group group_id="O1">
            <title>Senofilcon A With New UV Blocker (Test)</title>
            <description>Subjects that wore the senofilcon A with new UV blocker lens for the first 12-weeks of the study.</description>
          </group>
          <group group_id="O2">
            <title>Senofilcon A (Control)</title>
            <description>Subjects that wore the senofilcon A lens for the first 12 weeks of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eyes With Subject Reported Symptoms Problems or Complaints</title>
          <description>Symptoms, problems and complaints are subject reported and were collected for each subject eye at the 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data is reported as a binary outcome of yes if a subject experience a problem or complaint or no otherwise. Symptoms, problems and complaints include the following: Burning/Stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision and Other The Percentage of subjects eyes with symptoms, problems or complaints was reported for each lens and time point.</description>
          <population>All subjects that were dispensed at least one study lens.</population>
          <units>Percentage of eyes</units>
          <param>Number</param>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="134"/>
                <count group_id="O2" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.9"/>
                    <measurement group_id="O2" value="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.2"/>
                    <measurement group_id="O2" value="23.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.1"/>
                    <measurement group_id="O2" value="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.1"/>
                    <measurement group_id="O2" value="16.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.7"/>
                    <measurement group_id="O2" value="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Throughout the entire duration of study lens wear. Approximately 12-weeks per subject.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Senofilcon A With New UV Blocker</title>
          <description>Subjects that wore the senofilcon A with new UV blocker lens throughout the entire duration of the study.</description>
        </group>
        <group group_id="E2">
          <title>Senofilcon A</title>
          <description>Subjects that wore the senofilcon A lens throughout the entire duration 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="67"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </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="67"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </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>John Buch- SENIOR PRINCIPAL RESEARCH OPTOMETRIST</name_or_title>
      <organization>Johnson &amp; Johnson Vision</organization>
      <phone>904 443-1707</phone>
      <email>JBUCH@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/NCT02982018
org study id: CR-5638
nct id: NCT02982018
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Randomized, 8-visit dispensing study over 14 weeks to evaluate the safety and efficacy of an
      investigational contact lens with a new UV blocker compared to a marketed contact lens.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Eyestrain Related to Glare
time frame: Up to 12-Week Follow-up
description: Eyestrain related to glare was assessed at the 2-, 4-, 8- and 12- week follow-up visits using an 11-item questionnaire. This questionnaire assesses patient-experience attributes of soft contact lenses. Derived eyestrain related to glare scores using Item Response Theory (IRT) follow a normal distribution with a mean of 50 and a standard deviation of 10. Scores in this study ranged from 30 to 70. Lower scores indicate better performance. This questionnaire is still under development and the data collected is considered exploratory.
measure: Distance Monocular logMAR Visual Acuity (VA)
time frame: Up to 12-Week Follow-up
description: Distance logMAR Visual Acuity was assessed for each subject and eye at 2-, 4- 8- and 12-weeks. The average logMAR visual acuity for each lens and time point was reported. Lower values of logMAR indicate better vision.
measure: Percentage of Eyes With Grade 3 or Higher Slit Lamp Findings
time frame: Up to 12-Week Follow-up
description: Slit lamp findings were graded using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced. Measurements were taken in each subject eye at the initial visit, 2-4-8- and 12-week follow-ups. A new response variable was derived by dichotomizing the data as follows: 1 if a Grade 3or higher SLF was observed and 0 otherwise. The Percentage of eyes with Grade 3 or higher SLFs was reported for each lens and time point.
measure: Contact Lens Wearing Time
time frame: Up to 12-Week Follow-up
description: Contact lens wearing time (hours) was self-reported by each subject at the 2-, 4-, 8- and 12-week follow-ups. The average contact lens wearing time (hours) for each lens and time point was reported.
measure: Percentage of Eyes With Subject Reported Symptoms Problems or Complaints
time frame: Up to 12-Week Follow-up
description: Symptoms, problems and complaints are subject reported and were collected for each subject eye at the 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data is reported as a binary outcome of yes if a subject experience a problem or complaint or no otherwise. Symptoms, problems and complaints include the following: Burning/Stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision and Other The Percentage of subjects eyes with symptoms, problems or complaints was reported for each lens and time point.
arm group label: Investigational Contact Lens with UV Blocker
arm group type: Experimental
description: Subjects will be dispensed the investigational contact lens with UV blocker to wear daily for a period of 12 weeks with follow-up visits occurring after 1, 2, 4, 8, and 12 weeks. Afterwards, the subjects will wear their habitual contact lenses for a period of two weeks with weekly visits.
arm group label: Marketed Contact Lens
arm group type: Active Comparator
description: Subjects will be dispensed the marketed contact lens to wear daily for a period of 12 weeks with follow-up visits occurring after 1, 2, 4, 8, and 12 weeks. Afterwards, the subjects will wear their habitual contact lenses for a period of two weeks with weekly visits.
intervention type: Device
intervention name: senofilcon A with new UV blocker
description: Investigational Contact Lens
arm group label: Investigational Contact Lens with UV Blocker
intervention type: Device
intervention name: senofilcon A
description: J&J Marketed Contact Lens
arm group label: Marketed Contact Lens
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 