<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/NCT02251561</url>
  </required_header>
  <id_info>
    <org_study_id>CVKK2013-01</org_study_id>
    <nct_id>NCT02251561</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Opti-Free III (FID 109182) Compared to Opti-Free Plus® in Japan</brief_title>
  <official_title>Clinical Evaluation of Opti-Free III Compared to Opti-Free Plus®</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alcon Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alcon Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare an investigational contact lens care product (FID&#xD;
      109182) to a commercially available contact lens product (Opti-Free Plus®) for corneal&#xD;
      staining when used with Acuvue® Oasys® contact lenses. The contact lenses will be pre-soaked&#xD;
      in the products for 24-48 hours prior to a 2-hour contralateral wear period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein</measure>
    <time_frame>Day 1, after 2 hours of wear</time_frame>
    <description>The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining density was evaluated for each eye individually against representative pictures and scored on a 0-3 scale (0=No staining; 1=Staining with low density; 2=Staining with moderate density; 3=Staining with severe density). Proportion of participants is reported as a percentage.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein</measure>
    <time_frame>Day 1, after 2 hours of wear</time_frame>
    <description>The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining area was evaluated for each eye individually against representative pictures and scored on a 0-3 scale [0=No staining; 1=Staining with small area (1 to 25% of corneal surface); 2=Staining with medium area (26 to 50% of corneal surface); 3=Staining with large area (51% of corneal surface or greater)]. Proportion of participants is reported as a percentage.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Corneal Staining</condition>
  <arm_group>
    <arm_group_label>FID 109182</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Senofilcon A contact lens pre-soaked in FID 109182 worn in the right or left eye as randomized for 2 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Opti-Free Plus</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in the fellow eye for 2 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FID 109182</intervention_name>
    <description>Investigational multipurpose contact lens cleaning and disinfecting solution</description>
    <arm_group_label>FID 109182</arm_group_label>
    <other_name>Opti-Free III</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Opti-Free Plus</intervention_name>
    <description>Commercially available multipurpose contact lens cleaning and disinfecting solution</description>
    <arm_group_label>Opti-Free Plus</arm_group_label>
    <other_name>Opti-Free Plus®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Senofilcon A contact lens</intervention_name>
    <description>Commercially available silicone hydrogel contact lens</description>
    <arm_group_label>FID 109182</arm_group_label>
    <arm_group_label>Opti-Free Plus</arm_group_label>
    <other_name>Acuvue® Oasys®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Soft contact lenses habitual wearer, both eyes.&#xD;
&#xD;
          -  Voluntarily sign Informed Consent.&#xD;
&#xD;
          -  Other protocol-defined inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to tolerate the ingredients in Opti-Free® and similar contact lens care&#xD;
             products.&#xD;
&#xD;
          -  Potential use of eye drops during the study, including over-the-counter products,&#xD;
             except for artificial tear eye drops.&#xD;
&#xD;
          -  Eye infection, blepharitis, iris inflammation, or severe eye inflammation.&#xD;
&#xD;
          -  Corneal staining greater than Grade 1 at baseline.&#xD;
&#xD;
          -  Pregnant, lactating, or intend to become pregnant during study period.&#xD;
&#xD;
          -  Other protocol-defined exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tsunemitsu Senta</last_name>
    <role>Study Director</role>
    <affiliation>Alcon Japan, Ltd.</affiliation>
  </overall_official>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <results_first_submitted>May 20, 2015</results_first_submitted>
  <results_first_submitted_qc>June 3, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 10, 2015</results_first_posted>
  <last_update_submitted>June 3, 2015</last_update_submitted>
  <last_update_submitted_qc>June 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>contact lenses</keyword>
  <keyword>contact lens solution</keyword>
  <keyword>corneal staining</keyword>
  <keyword>fluorescein</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were enrolled from one study site located in Japan.</recruitment_details>
      <pre_assignment_details>Of the 36 subjects enrolled in the study, 8 were exited prior to product exposure [did not meet eligibility criteria (5), and subject withdrawal (3)]. This reporting group includes all subjects who used the study products (28).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>FID 109182/Opti-Free Plus</title>
          <description>Senofilcon A contact lens pre-soaked in FID 109182 in 1 eye, with senofilcon A contact lens pre-soaked in Opti-Free Plus in the fellow eye. Lenses worn contralaterally for 2 hours.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>This analysis population includes all subjects who used the study products.</population>
      <group_list>
        <group group_id="B1">
          <title>FID 109182/Opti-Free Plus</title>
          <description>Senofilcon A contact lens pre-soaked in FID 109182 in 1 eye, with senofilcon A contact lens pre-soaked in Opti-Free Plus in the fellow eye. Lenses worn contralaterally for 2 hours.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="28"/>
          </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="28.0" spread="7.5"/>
                  </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="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein</title>
        <description>The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining density was evaluated for each eye individually against representative pictures and scored on a 0-3 scale (0=No staining; 1=Staining with low density; 2=Staining with moderate density; 3=Staining with severe density). Proportion of participants is reported as a percentage.</description>
        <time_frame>Day 1, after 2 hours of wear</time_frame>
        <population>This analysis population includes all subjects who used the study products and had examination/observation data after use.</population>
        <group_list>
          <group group_id="O1">
            <title>FID 109182</title>
            <description>Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours</description>
          </group>
          <group group_id="O2">
            <title>Opti-Free Plus</title>
            <description>Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein</title>
          <description>The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining density was evaluated for each eye individually against representative pictures and scored on a 0-3 scale (0=No staining; 1=Staining with low density; 2=Staining with moderate density; 3=Staining with severe density). Proportion of participants is reported as a percentage.</description>
          <population>This analysis population includes all subjects who used the study products and had examination/observation data after use.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.6"/>
                    <measurement group_id="O2" value="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein</title>
        <description>The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining area was evaluated for each eye individually against representative pictures and scored on a 0-3 scale [0=No staining; 1=Staining with small area (1 to 25% of corneal surface); 2=Staining with medium area (26 to 50% of corneal surface); 3=Staining with large area (51% of corneal surface or greater)]. Proportion of participants is reported as a percentage.</description>
        <time_frame>Day 1, after 2 hours of wear</time_frame>
        <population>This analysis population includes all subjects who used the study products and had examination/observation data after use.</population>
        <group_list>
          <group group_id="O1">
            <title>FID 109182</title>
            <description>Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours</description>
          </group>
          <group group_id="O2">
            <title>Opti-Free Plus</title>
            <description>Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein</title>
          <description>The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining area was evaluated for each eye individually against representative pictures and scored on a 0-3 scale [0=No staining; 1=Staining with small area (1 to 25% of corneal surface); 2=Staining with medium area (26 to 50% of corneal surface); 3=Staining with large area (51% of corneal surface or greater)]. Proportion of participants is reported as a percentage.</description>
          <population>This analysis population includes all subjects who used the study products and had examination/observation data after use.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.6"/>
                    <measurement group_id="O2" value="44.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected for the duration of the study.</time_frame>
      <desc>This analysis population includes all subjects who used the study products. In this contralateral study, number at risk is presented by eye.</desc>
      <group_list>
        <group group_id="E1">
          <title>FID 109182</title>
          <description>Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours</description>
        </group>
        <group group_id="E2">
          <title>Opti-Free Plus</title>
          <description>Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </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="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </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>Sponsor reserves the right of prior review of any publication or presentation of information related to the study.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director, Clinical &amp; Regulatory Affairs, Division of Medical Affairs</name_or_title>
      <organization>Alcon Japan, Ltd.</organization>
      <email>alcon.medinfo@alcon.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/NCT02251561
org study id: CVKK2013-01
nct id: NCT02251561
lead sponsor: 
has dmc: No
The purpose of this study is to compare an investigational contact lens care product (FID
      109182) to a commercially available contact lens product (Opti-Free Plus®) for corneal
      staining when used with Acuvue® Oasys® contact lenses. The contact lenses will be pre-soaked
      in the products for 24-48 hours prior to a 2-hour contralateral wear period.
allocation: Randomized
intervention model: Single Group Assignment
masking: Double (Participant, Investigator)
measure: Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein
time frame: Day 1, after 2 hours of wear
description: The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining density was evaluated for each eye individually against representative pictures and scored on a 0-3 scale (0=No staining; 1=Staining with low density; 2=Staining with moderate density; 3=Staining with severe density). Proportion of participants is reported as a percentage.
measure: Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein
time frame: Day 1, after 2 hours of wear
description: The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining area was evaluated for each eye individually against representative pictures and scored on a 0-3 scale [0=No staining; 1=Staining with small area (1 to 25% of corneal surface); 2=Staining with medium area (26 to 50% of corneal surface); 3=Staining with large area (51% of corneal surface or greater)]. Proportion of participants is reported as a percentage.
arm group label: FID 109182
arm group type: Experimental
description: Senofilcon A contact lens pre-soaked in FID 109182 worn in the right or left eye as randomized for 2 hours
arm group label: Opti-Free Plus
arm group type: Active Comparator
description: Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in the fellow eye for 2 hours
intervention type: Device
intervention name: FID 109182
description: Investigational multipurpose contact lens cleaning and disinfecting solution
arm group label: FID 109182
other name: Opti-Free III
intervention type: Device
intervention name: Opti-Free Plus
description: Commercially available multipurpose contact lens cleaning and disinfecting solution
arm group label: Opti-Free Plus
other name: Opti-Free Plus®
intervention type: Device
intervention name: Senofilcon A contact lens
description: Commercially available silicone hydrogel contact lens
arm group label: FID 109182
arm group label: Opti-Free Plus
other name: Acuvue® Oasys®
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Tsunemitsu Senta
role: Study Director
affiliation: Alcon Japan, Ltd.
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 