<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/NCT03228212</url>
  </required_header>
  <id_info>
    <org_study_id>CR-5960</org_study_id>
    <nct_id>NCT03228212</nct_id>
  </id_info>
  <brief_title>Evaluation of Approved and Investigational Contact Lenses</brief_title>
  <official_title>Evaluation of Approved and Investigational Contact Lenses</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>
      This study is a randomized, 5-visit, partial subject masked, 2x3 bilateral crossover,&#xD;
      dispensing clinical trial. During the study, each test article will be worn in a daily wear&#xD;
      modality for at least 6 hours per day and 5 days per week for approximately 2 weeks each. The&#xD;
      subject will wear either the Test or Control article twice and the other study article once.&#xD;
      The primary objective of this study is to demonstrate that the Test lens works as well, if&#xD;
      not better compared to the Control lens with respect to CLUE (Contact Lens User Experience)&#xD;
      comfort, Slit Lamp findings, and Distance Monocular logMAR Visual Acuity. This study will&#xD;
      also aim to show acceptable lens fit for subjects wearing the Test lens.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 14, 2017</start_date>
  <completion_date type="Actual">September 18, 2017</completion_date>
  <primary_completion_date type="Actual">September 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Comfort</measure>
    <time_frame>2-Week Follow-up</time_frame>
    <description>Overall comfort 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. The average comfort score from the 3 study periods was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distance Monocular LogMAR Visual Acuity</measure>
    <time_frame>2-Week Follow-up</time_frame>
    <description>Distance Monocular LogMAR visual acuity was assessed at 4 meters using an ETDRS chart at the 2-week follow-up for each subject eye during each of the three study periods. The average visual acuity for each lens type from the 3 study periods was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Contact Lens Fitting Acceptance Rate</measure>
    <time_frame>Up to 2-Week Follow-up</time_frame>
    <description>Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope at post lens insertion and the 2-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported for each lens. The lens fit acceptance rate for both post lens fitting at the 2-week follow-up was reported for each lens type.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Grade 3 or Higher Slit Lamp Findings</measure>
    <time_frame>Up to 2-Week Follow-up</time_frame>
    <description>Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 2-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by lens was reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Quality of Vision</measure>
    <time_frame>2-Week Follow-up</time_frame>
    <description>Overall quality of 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. The average vision score from the 3 study periods was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Handling</measure>
    <time_frame>2-Week Follow-up</time_frame>
    <description>Overall Handling 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. The average handling score from the 3 study periods was reported.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">133</enrollment>
  <condition>Visual Acuity</condition>
  <arm_group>
    <arm_group_label>TEST/CONTROL/CONTROL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enrolled subjects will be habitual wearers of spherical contact lenses between the ages of 18 and 49 years old. Subjects will wear the Test and Control contact lenses bilaterally for approximately 2 weeks each on a daily wear basis. Subjects will be randomly assigned to one of the two lens wear sequences, (TEST/CONTROL/CONTROL)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CONTROL/TEST/TEST</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enrolled subjects will be habitual wearers of spherical contact lenses between the ages of 18 and 49 years old. Subjects will wear the Test and Control contact lenses bilaterally for approximately 2 weeks each on a daily wear basis. Subjects will be randomly assigned to one of the two lens wear sequences, (CONTROL/TEST/TEST)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CONTROL</intervention_name>
    <description>ACUVUE OASYS</description>
    <arm_group_label>CONTROL/TEST/TEST</arm_group_label>
    <arm_group_label>TEST/CONTROL/CONTROL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TEST</intervention_name>
    <description>senofilcon A with new UV blocker</description>
    <arm_group_label>CONTROL/TEST/TEST</arm_group_label>
    <arm_group_label>TEST/CONTROL/CONTROL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Potential subjects must satisfy all of the following inclusion criteria to be enrolled&#xD;
             in the study:&#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&#xD;
                  in this clinical protocol.&#xD;
&#xD;
               3. Healthy adult males or females age ≥18 and ≤49 years of age with signed informed&#xD;
                  consent. Eligible presbyopes will be those that wear full distance contact lenses&#xD;
                  in both eyes, 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 Diopter (D).&#xD;
&#xD;
               5. The subject's refractive cylinder must be ≤ 1.00D in each eye.&#xD;
&#xD;
               6. The subject must have visual acuity best correctable to 20/25+3 or better for&#xD;
                  each eye.&#xD;
&#xD;
               7. Subjects must own a wearable pair of spectacles.&#xD;
&#xD;
               8. The subject is a current spherical soft contact lens wearer (defined as a minimum&#xD;
                  of 6 hours of Daily Wear per day, at least 5 days per week, for a minimum of 1&#xD;
                  month prior to the study) and willing to wear the study lenses on a similar&#xD;
                  basis.&#xD;
&#xD;
               9. Subjects must be able and willing to wear the study lenses at least 6 hours a&#xD;
                  day, a minimum of 5 days per week&#xD;
&#xD;
              10. The subject must have normal eyes (i.e., no ocular medications or infections of&#xD;
                  any type).&#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 (subjects who become pregnant during the study&#xD;
                  will be discontinued).&#xD;
&#xD;
               2. Any systemic disease, autoimmune disease, or use of medication, which may&#xD;
                  interfere with contact lens wear. This may include, but not be limited to,&#xD;
                  diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome,&#xD;
                  xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive&#xD;
                  diseases or any 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,&#xD;
                  oral (e.g., Chlor-Trimeton, and Benadryl) and ophthalmic antihistamines, oral&#xD;
                  phenothiazines (e.g., Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine),&#xD;
                  oral and ophthalmic Beta-adrenergic blockers (e.g., Propranolol, Timolol, and&#xD;
                  Practolol), systemic steroids, and any prescribed or over the counter (OTC)&#xD;
                  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.&#xD;
&#xD;
               5. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy,&#xD;
                  photorefractive keratectomy (PRK), LASIK, etc.).&#xD;
&#xD;
               6. Any Grade 3 or greater slit lamp findings (e.g.., edema, corneal&#xD;
                  neovascularization, corneal staining, tarsal abnormalities, conjunctival&#xD;
                  injection) on the FDA classification scale, any previous history or signs of a&#xD;
                  contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or&#xD;
                  round peripheral scar), or any other ocular abnormality that may contraindicate&#xD;
                  contact lens wear.&#xD;
&#xD;
               7. Any known hypersensitivity or allergic reaction to Optifree®PureMoist®&#xD;
                  multi-purpose care solution or Eye-Cept® rewetting drop solution&#xD;
&#xD;
               8. Any ocular infection, allergy or clinically significant ocular disease (e.g.&#xD;
                  corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension),&#xD;
                  or ocular conditions (e.g. strabismus), which might interfere with the study.&#xD;
&#xD;
               9. Any corneal distortion resulting from previous hard or rigid gas permeable&#xD;
                  contact 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&#xD;
                  days prior to study enrollment.&#xD;
&#xD;
              12. Participation in clinical trials involving the Test lens within 3 months prior to&#xD;
                  study enrollment.&#xD;
&#xD;
              13. History of binocular vision abnormality or strabismus.&#xD;
&#xD;
              14. Employee, relative or friends of employees of any ophthalmic company, or&#xD;
                  investigational clinic (e.g., Investigator, Coordinator, Technician).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dr. James Weber &amp; Associates, PA</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vue Optical Boutique</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32250</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VisionCare Associates</name>
      <address>
        <city>East Lansing</city>
        <state>Michigan</state>
        <zip>48823</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pickens Family Eye Care</name>
      <address>
        <city>Pickens</city>
        <state>South Carolina</state>
        <zip>29671</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William J. Bogus, OD</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <results_first_submitted>September 14, 2018</results_first_submitted>
  <results_first_submitted_qc>December 12, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 13, 2018</results_first_posted>
  <last_update_submitted>December 12, 2018</last_update_submitted>
  <last_update_submitted_qc>December 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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>June 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03228212/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 133 subjects were enrolled into this study. Of the enrolled subjects, 130 were dispensed at least one study lens and 3 subjects failed to meet all eligibility criteria. Of the dispensed subjects 127 completed the study while 3 subjects were discontinued.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Test/Control/Control</title>
          <description>Subjects that wore the Test lens during the first period, and the control lens during the second and third period of the study.</description>
        </group>
        <group group_id="P2">
          <title>Control/Test/Test</title>
          <description>Subjects that wore the Control lens during the first period and the Test lens during the second and third 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="65"/>
                <participants group_id="P2" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="64"/>
                <participants group_id="P2" count="64"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </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>no longer meets eligibility criteria</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="64"/>
                <participants group_id="P2" count="64"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="63"/>
                <participants group_id="P2" count="64"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 3</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="63"/>
                <participants group_id="P2" count="64"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="63"/>
                <participants group_id="P2" count="64"/>
              </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>
      <group_list>
        <group group_id="B1">
          <title>Dispensed Subjects</title>
          <description>All subjects that were dispensed at least one study lens.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="130"/>
          </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="31.6" spread="7.69"/>
                  </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="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Comfort</title>
        <description>Overall comfort 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. The average comfort score from the 3 study periods was reported.</description>
        <time_frame>2-Week Follow-up</time_frame>
        <population>All subjects that completed all study visits without a major protocol deviation.</population>
        <group_list>
          <group group_id="O1">
            <title>Test</title>
            <description>Subjects that wore the Test lens during any of the 3 periods of the study.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Subjects that wore the Control lens during any of the 3 periods of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Comfort</title>
          <description>Overall comfort 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. The average comfort score from the 3 study periods was reported.</description>
          <population>All 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="121"/>
                <count group_id="O2" value="121"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.509" spread="23.8724"/>
                    <measurement group_id="O2" value="61.185" spread="24.2024"/>
                  </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>It was calculated that 60 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 5 points difference in mean overall comfort at the 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>5.1</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>2.0</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.16</ci_lower_limit>
            <ci_upper_limit>9.09</ci_upper_limit>
            <estimate_desc>Mean difference was calculated as Test - Control</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Distance Monocular LogMAR Visual Acuity</title>
        <description>Distance Monocular LogMAR visual acuity was assessed at 4 meters using an ETDRS chart at the 2-week follow-up for each subject eye during each of the three study periods. The average visual acuity for each lens type from the 3 study periods was reported.</description>
        <time_frame>2-Week Follow-up</time_frame>
        <population>All subjects that completed all study visits without a major protocol deviation.</population>
        <group_list>
          <group group_id="O1">
            <title>Test</title>
            <description>Subjects that wore the Test lens during any of the 3 periods of the study.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Subjects that wore the Control lens during any of the 3 periods of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Distance Monocular LogMAR Visual Acuity</title>
          <description>Distance Monocular LogMAR visual acuity was assessed at 4 meters using an ETDRS chart at the 2-week follow-up for each subject eye during each of the three study periods. The average visual acuity for each lens type from the 3 study periods was reported.</description>
          <population>All 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="65"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
                <count group_id="O2" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.095" spread="0.0831"/>
                    <measurement group_id="O2" value="-0.075" spread="0.0806"/>
                  </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>It was calculated that 40 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 0.05 difference in LogMAR visual acuity at the 2-week follow-up. Sample size was determined using simulations methods for repeated measures.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>A non-inferiority margin of 0.05 logmar was used. This margin corresponds to a half line difference.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.02</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.00621</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.01</ci_lower_limit>
            <ci_upper_limit>0.03</ci_upper_limit>
            <estimate_desc>Mean difference was calculated as Test - Control</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Contact Lens Fitting Acceptance Rate</title>
        <description>Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope at post lens insertion and the 2-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported for each lens. The lens fit acceptance rate for both post lens fitting at the 2-week follow-up was reported for each lens type.</description>
        <time_frame>Up to 2-Week Follow-up</time_frame>
        <population>Subjects that completed all study visits.</population>
        <group_list>
          <group group_id="O1">
            <title>Test</title>
            <description>Subjects that wore the Test lens during any of the 3 periods of the study.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Subjects that wore the Control lens during any of the 3 periods of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Contact Lens Fitting Acceptance Rate</title>
          <description>Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope at post lens insertion and the 2-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported for each lens. The lens fit acceptance rate for both post lens fitting at the 2-week follow-up was reported for each lens type.</description>
          <population>Subjects that completed all study visits.</population>
          <units>proportion 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="65"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
                <count group_id="O2" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>It was calculated that 70 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a the 2-week follow-up. Sample size was determined using simulations methods for repeated measures. Analysis was only performed on eyes wearing the Tesl lens.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>A non-inferiority margin of 90% was used. Lower limit of 95% credible interval was compared to 90%</non_inferiority_desc>
            <param_type>proportion</param_type>
            <param_value>0.992</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.96</ci_lower_limit>
            <ci_upper_limit>1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Grade 3 or Higher Slit Lamp Findings</title>
        <description>Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 2-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by lens was reported.</description>
        <time_frame>Up to 2-Week Follow-up</time_frame>
        <population>Subjects that were dispensed at least one study lens.</population>
        <group_list>
          <group group_id="O1">
            <title>Test</title>
            <description>Subjects that wore the Test lens during any of the 3 periods of the study.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Subjects that wore the Control lens during any of the 3 periods of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Grade 3 or Higher Slit Lamp Findings</title>
          <description>Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 2-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by lens was reported.</description>
          <population>Subjects that were dispensed at least one study lens.</population>
          <units>Slit Lamp Finding</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="65"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
                <count group_id="O2" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </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>It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect 5% difference between the Test and Control lens with respect to the proportion of eyes with Grade 3 or higher slit lamp findings across all study visits. Sample size was determined using simulations methods. Sample size for this study was primarily driven by the slit lamp findings.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>A non-inferiority margin of 5% was used. Upper limit of the 95% credible interval was compared to 5%</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.0043</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.0089</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0237</ci_lower_limit>
            <ci_upper_limit>0.0129</ci_upper_limit>
            <estimate_desc>Mean difference calculated as Test - Control</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Quality of Vision</title>
        <description>Overall quality of 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. The average vision score from the 3 study periods was reported.</description>
        <time_frame>2-Week Follow-up</time_frame>
        <population>All subjects that completed all study visits without a major protocol deviation.</population>
        <group_list>
          <group group_id="O1">
            <title>Test</title>
            <description>Subjects that wore the Test lens during any of the 3 periods of the study.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Subjects that wore the Control lens during any of the 3 periods of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Quality of Vision</title>
          <description>Overall quality of 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. The average vision score from the 3 study periods was reported.</description>
          <population>All 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="121"/>
                <count group_id="O2" value="121"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.16" spread="20.362"/>
                    <measurement group_id="O2" value="60.329" spread="22.289"/>
                  </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>Sample size calculations were based on the primary endpoints.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>7.2</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.8</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.69</ci_lower_limit>
            <ci_upper_limit>10.74</ci_upper_limit>
            <estimate_desc>Mean difference was calculated as Test - Control</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Handling</title>
        <description>Overall Handling 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. The average handling score from the 3 study periods was reported.</description>
        <time_frame>2-Week Follow-up</time_frame>
        <population>All subjects that completed all study visits without a major protocol deviation.</population>
        <group_list>
          <group group_id="O1">
            <title>Test</title>
            <description>Subjects that wore the Test lens during any of the 3 periods of the study.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Subjects that wore the Control lens during any of the 3 periods of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Handling</title>
          <description>Overall Handling 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. The average handling score from the 3 study periods was reported.</description>
          <population>All 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="121"/>
                <count group_id="O2" value="121"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.11" spread="20.046"/>
                    <measurement group_id="O2" value="66.79" spread="20.007"/>
                  </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>Sample size calculations were based on the primary endpoints.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3.3</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.5</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.36</ci_lower_limit>
            <ci_upper_limit>6.29</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 entire duration of the study. Approximately 6 weeks per subject.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Test</title>
          <description>Subjects that wore the Test lens during any of the 3 periods of the study.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Subjects that wore the Control lens during any of the 3 periods 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="130"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="130"/>
              </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="130"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="130"/>
              </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 Care Inc.</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/NCT03228212
org study id: CR-5960
nct id: NCT03228212
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study is a randomized, 5-visit, partial subject masked, 2x3 bilateral crossover,
      dispensing clinical trial. During the study, each test article will be worn in a daily wear
      modality for at least 6 hours per day and 5 days per week for approximately 2 weeks each. The
      subject will wear either the Test or Control article twice and the other study article once.
      The primary objective of this study is to demonstrate that the Test lens works as well, if
      not better compared to the Control lens with respect to CLUE (Contact Lens User Experience)
      comfort, Slit Lamp findings, and Distance Monocular logMAR Visual Acuity. This study will
      also aim to show acceptable lens fit for subjects wearing the Test lens.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Overall Comfort
time frame: 2-Week Follow-up
description: Overall comfort 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. The average comfort score from the 3 study periods was reported.
measure: Distance Monocular LogMAR Visual Acuity
time frame: 2-Week Follow-up
description: Distance Monocular LogMAR visual acuity was assessed at 4 meters using an ETDRS chart at the 2-week follow-up for each subject eye during each of the three study periods. The average visual acuity for each lens type from the 3 study periods was reported.
measure: Contact Lens Fitting Acceptance Rate
time frame: Up to 2-Week Follow-up
description: Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope at post lens insertion and the 2-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported for each lens. The lens fit acceptance rate for both post lens fitting at the 2-week follow-up was reported for each lens type.
measure: Number of Grade 3 or Higher Slit Lamp Findings
time frame: Up to 2-Week Follow-up
description: Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 2-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by lens was reported.
measure: Overall Quality of Vision
time frame: 2-Week Follow-up
description: Overall quality of 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. The average vision score from the 3 study periods was reported.
measure: Overall Handling
time frame: 2-Week Follow-up
description: Overall Handling 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. The average handling score from the 3 study periods was reported.
arm group label: TEST/CONTROL/CONTROL
arm group type: Experimental
description: Enrolled subjects will be habitual wearers of spherical contact lenses between the ages of 18 and 49 years old. Subjects will wear the Test and Control contact lenses bilaterally for approximately 2 weeks each on a daily wear basis. Subjects will be randomly assigned to one of the two lens wear sequences, (TEST/CONTROL/CONTROL)
arm group label: CONTROL/TEST/TEST
arm group type: Experimental
description: Enrolled subjects will be habitual wearers of spherical contact lenses between the ages of 18 and 49 years old. Subjects will wear the Test and Control contact lenses bilaterally for approximately 2 weeks each on a daily wear basis. Subjects will be randomly assigned to one of the two lens wear sequences, (CONTROL/TEST/TEST)
intervention type: Device
intervention name: CONTROL
description: ACUVUE OASYS
arm group label: CONTROL/TEST/TEST
arm group label: TEST/CONTROL/CONTROL
intervention type: Device
intervention name: TEST
description: senofilcon A with new UV blocker
arm group label: CONTROL/TEST/TEST
arm group label: TEST/CONTROL/CONTROL
criteria: 
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
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facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided
provided document: 
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 