<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/NCT03755882</url>
  </required_header>
  <id_info>
    <org_study_id>CR-6286</org_study_id>
    <nct_id>NCT03755882</nct_id>
  </id_info>
  <brief_title>Clinical Comparison of Two Marketed Reusable Cosmetic Contact Lenses</brief_title>
  <official_title>Clinical Comparison of Two Marketed Reusable Cosmetic 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 will be a 4-visit, multi-site, randomized, brand-masked, bilateral, 2×2 crossover study.&#xD;
      If a subject is found to meet all eligibility criteria, they will be randomized to one of two&#xD;
      lens wear sequences. Each lens type will be worn for approximately 2 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 5, 2018</start_date>
  <completion_date type="Actual">December 26, 2018</completion_date>
  <primary_completion_date type="Actual">December 26, 2018</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>Visual Performance</measure>
    <time_frame>Up to 2-Week Follow-up</time_frame>
    <description>Monocular visual performance (logMAR) was evaluated under 3 conditions (1.high luminance and high contrast, 2. High Lumiance Low Contrast and 3. Low Luminance High Contrast with distance goggles) at 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Letter-by-letter results were calculated to ascertain the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Visual Acuity</condition>
  <arm_group>
    <arm_group_label>TEST/CONTROL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Female subjects between the ages of 18 to 29 years who are habitual reusable soft cosmetic contact lens wearers will be randomized into one of two lens sequences.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CONTROL/TEST</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Female subjects between the ages of 18 to 29 years who are habitual reusable soft cosmetic contact lens wearers will be randomized into one of two lens sequences.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ACUVUE® DEFINE™ Vivid Style</intervention_name>
    <description>TEST Lens</description>
    <arm_group_label>CONTROL/TEST</arm_group_label>
    <arm_group_label>TEST/CONTROL</arm_group_label>
    <other_name>etafilcon A</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LACELLE™ Sparkling Brown</intervention_name>
    <description>CONTROL Lens</description>
    <arm_group_label>CONTROL/TEST</arm_group_label>
    <arm_group_label>TEST/CONTROL</arm_group_label>
    <other_name>helifilcon A</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Potential subjects must satisfy all of the following criteria to be enrolled in the&#xD;
             study:&#xD;
&#xD;
               1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and&#xD;
                  receive a fully executed copy of the form.&#xD;
&#xD;
               2. Appear able and willing to adhere to the instructions set forth in this clinical&#xD;
                  protocol (ie, willing to wear only the study lenses and not use habitual lenses&#xD;
                  during the study).&#xD;
&#xD;
               3. Females between 18 and 29 (inclusive) years of age at the time of screening&#xD;
&#xD;
               4. The subject's vertex corrected spherical equivalent distance refraction must be&#xD;
                  in the range of -2.00 D to -7.00 D (inclusive) in each eye.&#xD;
&#xD;
               5. The subject's refractive cylinder must be less than or equal to 0.75 D&#xD;
                  (inclusive) in each eye.&#xD;
&#xD;
               6. Have spherical best corrected logMAR visual acuity (VA) of 0.18 or better in each&#xD;
                  eye.&#xD;
&#xD;
               7. Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day&#xD;
                  and 5 days/week over the last month by self-report.&#xD;
&#xD;
               8. Must be habitual reusable (2 week, or monthly), cosmetic contact lenses wearers.&#xD;
&#xD;
               9. The subject must be willing to be photographed and/or video-taped&#xD;
&#xD;
                  Exclusion Criteria:&#xD;
&#xD;
          -  Potential subjects who meet any of the following criteria will be excluded from&#xD;
             participating in the study:&#xD;
&#xD;
               1. Currently pregnant or lactating&#xD;
&#xD;
               2. Any systemic disease (eg, Sjögren's Syndrome), allergies, infectious disease (eg,&#xD;
                  hepatitis, tuberculosis), contagious immunosuppressive diseases (eg, HIV),&#xD;
                  autoimmune disease (eg rheumatoid arthritis), or other diseases, by self-report,&#xD;
                  which are known to interfere with contact lens wear and/or participation in the&#xD;
                  study (at the investigators discretion).&#xD;
&#xD;
               3. Use of systemic medications (eg, chronic steroid use) that are known to interfere&#xD;
                  with contact lens wear (at the investigators discretion).&#xD;
&#xD;
               4. Any previous, or planned (during the study) ocular surgery (eg, radial&#xD;
                  keratotomy, PRK, LASIK, etc.)&#xD;
&#xD;
               5. Participation in any contact lens or lens care product clinical trial within&#xD;
                  seven (7) days prior to study enrollment.&#xD;
&#xD;
               6. Employee or family members of clinical site (eg, Investigator, Coordinator,&#xD;
                  Technician).&#xD;
&#xD;
               7. Any ocular allergies, infections or other ocular abnormalities that are known to&#xD;
                  interfere with contact lens wear and/or participation in the study. This may&#xD;
                  include, but not be limited to entropion, ectropion, extrusions, chalazia,&#xD;
                  recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or&#xD;
                  corneal distortion (at the investigators discretion).&#xD;
&#xD;
               8. Clinically significant (Grade 3 or 4 on FDA scale) tarsal abnormalities, bulbar&#xD;
                  injection, corneal edema, corneal vascularization, corneal staining, or any other&#xD;
                  abnormalities of the cornea which would contraindicate contact lens wear.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sun Yat-Sen University Zhongshan Ophthalmic Center</name>
      <address>
        <city>Guanzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <results_first_submitted>December 23, 2019</results_first_submitted>
  <results_first_submitted_qc>December 23, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 10, 2020</results_first_posted>
  <last_update_submitted>January 23, 2020</last_update_submitted>
  <last_update_submitted_qc>January 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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>December 20, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT03755882/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 46 subjects were enrolled into this study. Of those enrolled 45 were dispensed at least 1 study lens. Of those dispensed, 41 subjects completed the study while 4 were discontinued.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Test/Control</title>
          <description>Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period</description>
        </group>
        <group group_id="P2">
          <title>Control/Test</title>
          <description>Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unsatisfactory Lens Fitting Test Article</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </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="19"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Total</title>
          <description>All subjects dispensed a study lens</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="45"/>
          </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="23.6" spread="2.80"/>
                  </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_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Visual Performance</title>
        <description>Monocular visual performance (logMAR) was evaluated under 3 conditions (1.high luminance and high contrast, 2. High Lumiance Low Contrast and 3. Low Luminance High Contrast with distance goggles) at 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Letter-by-letter results were calculated to ascertain the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.</description>
        <time_frame>Up to 2-Week Follow-up</time_frame>
        <population>All subjects who had successfully completed all visits.</population>
        <group_list>
          <group group_id="O1">
            <title>Test (Etafilcon A)</title>
            <description>Subjects that wore the Test lens in either the first or second period of the study.</description>
          </group>
          <group group_id="O2">
            <title>Control (Hefilcon A)</title>
            <description>Subjects that wore the Control lens in either the first or second period of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Performance</title>
          <description>Monocular visual performance (logMAR) was evaluated under 3 conditions (1.high luminance and high contrast, 2. High Lumiance Low Contrast and 3. Low Luminance High Contrast with distance goggles) at 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Letter-by-letter results were calculated to ascertain the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.</description>
          <population>All subjects who had successfully completed all visits.</population>
          <units>logMAR Units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>High Luminnance Low Contrast</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="41"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.40" spread="0.074"/>
                    <measurement group_id="O2" value="0.38" spread="0.086"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High Luminance High Contrast</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="41"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.09" spread="0.053"/>
                    <measurement group_id="O2" value="-0.10" spread="0.059"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Low Luminance High Contrast with Distance Goggles</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="41"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Eyes</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" spread="0.055"/>
                    <measurement group_id="O2" value="-0.09" spread="0.055"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Throughout the duration of the study. Approximately 5 weeks per subject.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Test (Etafilcon A)</title>
          <description>Subjects that wore the Test lens in either the first or second period of the study.</description>
        </group>
        <group group_id="E2">
          <title>Control (Hefilcon A)</title>
          <description>Subjects that wore the Control lens in either the first or second period of the study.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Brian Pall, OD, MS, FAAO- Director of clinical Sciences</name_or_title>
      <organization>Johnson &amp; Johnson Vision Care Inc.</organization>
      <phone>904 443-1290</phone>
      <email>BPALL@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/NCT03755882
org study id: CR-6286
nct id: NCT03755882
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This will be a 4-visit, multi-site, randomized, brand-masked, bilateral, 2×2 crossover study.
      If a subject is found to meet all eligibility criteria, they will be randomized to one of two
      lens wear sequences. Each lens type will be worn for approximately 2 weeks.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Visual Performance
time frame: Up to 2-Week Follow-up
description: Monocular visual performance (logMAR) was evaluated under 3 conditions (1.high luminance and high contrast, 2. High Lumiance Low Contrast and 3. Low Luminance High Contrast with distance goggles) at 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Letter-by-letter results were calculated to ascertain the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
arm group label: TEST/CONTROL
arm group type: Experimental
description: Female subjects between the ages of 18 to 29 years who are habitual reusable soft cosmetic contact lens wearers will be randomized into one of two lens sequences.
arm group label: CONTROL/TEST
arm group type: Experimental
description: Female subjects between the ages of 18 to 29 years who are habitual reusable soft cosmetic contact lens wearers will be randomized into one of two lens sequences.
intervention type: Device
intervention name: ACUVUE® DEFINE™ Vivid Style
description: TEST Lens
arm group label: CONTROL/TEST
arm group label: TEST/CONTROL
other name: etafilcon A
intervention type: Device
intervention name: LACELLE™ Sparkling Brown
description: CONTROL Lens
arm group label: CONTROL/TEST
arm group label: TEST/CONTROL
other name: helifilcon A
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 29 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 