<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/NCT03278223</url>
  </required_header>
  <id_info>
    <org_study_id>OTES-3301</org_study_id>
    <nct_id>NCT03278223</nct_id>
  </id_info>
  <brief_title>One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System</brief_title>
  <official_title>One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OTE North America</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Visioncare Research Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>OTE North America</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_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the clinical performance of the contact lens care&#xD;
      product Oté Sensation in a representative population of soft contact lens wearers. For&#xD;
      comparison, a widely used FDA approved soft lens multipurpose solution will be used as a&#xD;
      control. This control product has been tested in previous clinical trials.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a 1-month, 200-subject, double-masked (care product), bilateral, randomized,&#xD;
      comparative study. Subjects will be clinically evaluated at the initial baseline visit (Visit&#xD;
      1), then after 1 week and 1 month of lens wear having been randomly assigned to use one of&#xD;
      six lens types and to either the test or control solutions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2017</start_date>
  <completion_date type="Actual">December 20, 2017</completion_date>
  <primary_completion_date type="Actual">November 17, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comfort</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Subjective comfort(during the day). Subject grading comfort of lenses 0-10 (Higher scores indicates the subjects greater comfort with the lenses.)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Acuity (VA)</measure>
    <time_frame>Visual Acuity was assessed for all participants after 2 weeks from day of dispensing lens solution and then again at the final evaluation at the 1 month visit.</time_frame>
    <description>Monocular and binocular high contrast Visual Acuity (VA) was measured at each visit and evaluated using a LogMAR VA Chart where the size of the letters become increasingly smaller from the top of the chart to the bottom of the chart. On this scale, the minimum VA (Worst achievable) is +1.00 LogMAR and the maximum value (Best achievable) is -0.30 LogMAR. Each line of the chart (a total of five letters per line) is equivalent to -0.10 LogMAR and each letter read is equivalent to -0.02. The lower the score/measurement , indicate a better VA obtained. Participants were positioned at a distance of three meters from the eye chart and asked to start reading letters from the top line and to continuing reading letters until they are unable to correctly identify three letters on any given line. The Visual Acuity was recorded to the nearest letter.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lens Surface Wetting</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Lens surface wettability rated on the appearance of the lens surface and the drying time viewed with a slit lamp under low magnification. 0-4 scale (4 = Excellent)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Film Deposits</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Any film deposits (protein/lipid) attached to the front surface of the lens. Scan the entire lens surface (10- 20X) for the presence of deposits. 0-4 (4= Heavy film)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Corneal Staining</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Assessed using a slit lamp by sector with fluorescein, blue light, yellow filter and full beam using a medium magnification. Cornea staining will be assessed by sector (Central, Nasal, Temporal, Inferior, Superior) using a 0-4 scale where 0-4 is the total corneal staining score and higher staining score indicates a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Limbal Hyperemia</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Assessed using slit lamp with white light, low-medium magnification. 0-4 ( 4= Severe)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bulbar Hyperemia</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Assessed using slit lamp with white light, low-medium magnification 0-4 ( 4= Severe)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">194</enrollment>
  <condition>Myopia</condition>
  <condition>Hyperopia</condition>
  <arm_group>
    <arm_group_label>Test solution</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control solution</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Test solution</intervention_name>
    <description>A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.</description>
    <arm_group_label>Test solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control solution</intervention_name>
    <description>A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.</description>
    <arm_group_label>Control solution</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be a currently adapted soft contact lens wearer (&gt;1 month of lens wear).&#xD;
&#xD;
          -  Be at least 18 years of age.&#xD;
&#xD;
          -  Refractive astigmatism &lt;0.75 D in both eyes.&#xD;
&#xD;
          -  Have clear corneas and be free of any anterior segment disorders.&#xD;
&#xD;
          -  Be correctable through spherocylindrical refraction to 6/12 (20/40) (0.30 LogMAR) or&#xD;
             better in each eye.&#xD;
&#xD;
          -  Contact lens sphere requirement between +4.00 Dioptre and -8.00 D (inclusive).&#xD;
&#xD;
          -  Require visual correction in both eyes (monovision allowed, no monofit).&#xD;
&#xD;
          -  Have normal eyes with no evidence of abnormality or disease. For the purposes of this&#xD;
             study a normal eye is defined as one having:&#xD;
&#xD;
               1. No amblyopia&#xD;
&#xD;
               2. No strabismus&#xD;
&#xD;
               3. No evidence of lid abnormality or infection&#xD;
&#xD;
               4. No conjunctival abnormality or infection that would contraindicate contact lens&#xD;
                  wear&#xD;
&#xD;
               5. No clinically significant slit lamp findings (i.e. corneal staining, stromal&#xD;
                  edema, staining, scarring, vascularization, infiltrates or abnormal opacities)&#xD;
&#xD;
               6. No other active ocular disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Require toric or multifocal contact lenses.&#xD;
&#xD;
          -  Previously shown a sensitivity to any of the study solution components.&#xD;
&#xD;
          -  Any systemic or ocular disease or allergies affecting ocular health.&#xD;
&#xD;
          -  Using systemic or topical medications that will in the investigator's opinion affect&#xD;
             ocular physiology or lens performance.&#xD;
&#xD;
          -  Clinically significant (&gt;Grade 3) corneal staining, corneal stromal edema, corneal&#xD;
             vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any&#xD;
             other abnormality of the cornea that would contraindicate contact lens wear.&#xD;
&#xD;
          -  Any corneal infiltrates or any corneal scarring or neovascularization within the&#xD;
             central 5mm of the cornea.&#xD;
&#xD;
          -  Keratoconus or other corneal irregularity.&#xD;
&#xD;
          -  Aphakia or amblyopia.&#xD;
&#xD;
          -  Have undergone corneal refractive surgery or any anterior segment surgery.&#xD;
&#xD;
          -  Abnormal lacrimal secretions.&#xD;
&#xD;
          -  Has diabetes.&#xD;
&#xD;
          -  Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an&#xD;
             immunosuppressive disease (e.g., HIV).&#xD;
&#xD;
          -  History of chronic eye disease (e.g. glaucoma).&#xD;
&#xD;
          -  Pregnant or lactating or planning a pregnancy at the time of enrolment.&#xD;
&#xD;
          -  Participation in any concurrent clinical trial or in last 30 days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frances L Nicklin, Bsc, MCOptom</last_name>
    <role>Principal Investigator</role>
    <affiliation>Visioncare Research Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Golden Vision</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kannarr Eye Care</name>
      <address>
        <city>Pittsburg</city>
        <state>Kansas</state>
        <zip>66762</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sacco Eye Group</name>
      <address>
        <city>Vestal</city>
        <state>New York</state>
        <zip>13850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Optometry Group PLLC</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frazier Vision, Inc.</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eyesite</name>
      <address>
        <city>Reading</city>
        <state>Berkshire</state>
        <zip>RG1 1EX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leightons and Tempany</name>
      <address>
        <city>Poole</city>
        <state>Bournemouth</state>
        <zip>BH15 1AU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brock and Houlford</name>
      <address>
        <city>Chew Magna</city>
        <state>Bristol</state>
        <zip>BS40 8PR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harrold Opticians</name>
      <address>
        <city>Uxbridge</city>
        <state>Middlesex</state>
        <zip>UB8 1JX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Contact</name>
      <address>
        <city>Eastcote</city>
        <state>Pinner</state>
        <zip>HA5 1RJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visioncare Research Ltd</name>
      <address>
        <city>Farnham</city>
        <state>Surrey</state>
        <zip>GU9 7EN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <results_first_submitted>August 30, 2019</results_first_submitted>
  <results_first_submitted_qc>March 2, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 26, 2021</results_first_posted>
  <last_update_submitted>March 2, 2021</last_update_submitted>
  <last_update_submitted_qc>March 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multipurpose Contact Lens Care System</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperopia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_browse>
  <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>July 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT03278223/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 27, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT03278223/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Test Solution</title>
          <description>A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.&#xD;
Test solution: A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.</description>
        </group>
        <group group_id="P2">
          <title>Control Solution</title>
          <description>A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.&#xD;
Control solution: A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="125"/>
                <participants group_id="P2" count="69"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="122"/>
                <participants group_id="P2" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Test Solution</title>
          <description>A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.&#xD;
Test solution: A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.</description>
        </group>
        <group group_id="B2">
          <title>Control Solution</title>
          <description>A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.&#xD;
Control solution: A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="125"/>
            <count group_id="B2" value="69"/>
            <count group_id="B3" value="194"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="125"/>
                    <count group_id="B2" value="69"/>
                    <count group_id="B3" value="194"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="125"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="191"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="125"/>
                    <count group_id="B2" value="69"/>
                    <count group_id="B3" value="194"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="139"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Comfort</title>
        <description>Subjective comfort(during the day). Subject grading comfort of lenses 0-10 (Higher scores indicates the subjects greater comfort with the lenses.)</description>
        <time_frame>Up to 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Solution</title>
            <description>A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.</description>
          </group>
          <group group_id="O2">
            <title>Control Solution</title>
            <description>A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.</description>
          </group>
        </group_list>
        <measure>
          <title>Comfort</title>
          <description>Subjective comfort(during the day). Subject grading comfort of lenses 0-10 (Higher scores indicates the subjects greater comfort with the lenses.)</description>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="122"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.44" spread="0.31"/>
                    <measurement group_id="O2" value="8.11" spread="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Acuity (VA)</title>
        <description>Monocular and binocular high contrast Visual Acuity (VA) was measured at each visit and evaluated using a LogMAR VA Chart where the size of the letters become increasingly smaller from the top of the chart to the bottom of the chart. On this scale, the minimum VA (Worst achievable) is +1.00 LogMAR and the maximum value (Best achievable) is -0.30 LogMAR. Each line of the chart (a total of five letters per line) is equivalent to -0.10 LogMAR and each letter read is equivalent to -0.02. The lower the score/measurement , indicate a better VA obtained. Participants were positioned at a distance of three meters from the eye chart and asked to start reading letters from the top line and to continuing reading letters until they are unable to correctly identify three letters on any given line. The Visual Acuity was recorded to the nearest letter.</description>
        <time_frame>Visual Acuity was assessed for all participants after 2 weeks from day of dispensing lens solution and then again at the final evaluation at the 1 month visit.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Solution</title>
            <description>A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.</description>
          </group>
          <group group_id="O2">
            <title>Control Solution</title>
            <description>A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Acuity (VA)</title>
          <description>Monocular and binocular high contrast Visual Acuity (VA) was measured at each visit and evaluated using a LogMAR VA Chart where the size of the letters become increasingly smaller from the top of the chart to the bottom of the chart. On this scale, the minimum VA (Worst achievable) is +1.00 LogMAR and the maximum value (Best achievable) is -0.30 LogMAR. Each line of the chart (a total of five letters per line) is equivalent to -0.10 LogMAR and each letter read is equivalent to -0.02. The lower the score/measurement , indicate a better VA obtained. Participants were positioned at a distance of three meters from the eye chart and asked to start reading letters from the top line and to continuing reading letters until they are unable to correctly identify three letters on any given line. The Visual Acuity was recorded to the nearest letter.</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="122"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.01"/>
                    <measurement group_id="O2" value="-0.02" spread="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lens Surface Wetting</title>
        <description>Lens surface wettability rated on the appearance of the lens surface and the drying time viewed with a slit lamp under low magnification. 0-4 scale (4 = Excellent)</description>
        <time_frame>Up to 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Solution</title>
            <description>A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.</description>
          </group>
          <group group_id="O2">
            <title>Control Solution</title>
            <description>A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.</description>
          </group>
        </group_list>
        <measure>
          <title>Lens Surface Wetting</title>
          <description>Lens surface wettability rated on the appearance of the lens surface and the drying time viewed with a slit lamp under low magnification. 0-4 scale (4 = Excellent)</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="122"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.33" spread="0.17"/>
                    <measurement group_id="O2" value="3.28" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Film Deposits</title>
        <description>Any film deposits (protein/lipid) attached to the front surface of the lens. Scan the entire lens surface (10- 20X) for the presence of deposits. 0-4 (4= Heavy film)</description>
        <time_frame>Up to 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Solution</title>
            <description>A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.</description>
          </group>
          <group group_id="O2">
            <title>Control Solution</title>
            <description>A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.</description>
          </group>
        </group_list>
        <measure>
          <title>Film Deposits</title>
          <description>Any film deposits (protein/lipid) attached to the front surface of the lens. Scan the entire lens surface (10- 20X) for the presence of deposits. 0-4 (4= Heavy film)</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="122"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.37" spread="0.12"/>
                    <measurement group_id="O2" value="0.57" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Corneal Staining</title>
        <description>Assessed using a slit lamp by sector with fluorescein, blue light, yellow filter and full beam using a medium magnification. Cornea staining will be assessed by sector (Central, Nasal, Temporal, Inferior, Superior) using a 0-4 scale where 0-4 is the total corneal staining score and higher staining score indicates a worse outcome.</description>
        <time_frame>Up to 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Solution</title>
            <description>A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.</description>
          </group>
          <group group_id="O2">
            <title>Control Solution</title>
            <description>A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.</description>
          </group>
        </group_list>
        <measure>
          <title>Corneal Staining</title>
          <description>Assessed using a slit lamp by sector with fluorescein, blue light, yellow filter and full beam using a medium magnification. Cornea staining will be assessed by sector (Central, Nasal, Temporal, Inferior, Superior) using a 0-4 scale where 0-4 is the total corneal staining score and higher staining score indicates a worse outcome.</description>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="122"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="0.04"/>
                    <measurement group_id="O2" value="0.27" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Limbal Hyperemia</title>
        <description>Assessed using slit lamp with white light, low-medium magnification. 0-4 ( 4= Severe)</description>
        <time_frame>Up to 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Solution</title>
            <description>A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.</description>
          </group>
          <group group_id="O2">
            <title>Control Solution</title>
            <description>A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.</description>
          </group>
        </group_list>
        <measure>
          <title>Limbal Hyperemia</title>
          <description>Assessed using slit lamp with white light, low-medium magnification. 0-4 ( 4= Severe)</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="122"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.43" spread="0.12"/>
                    <measurement group_id="O2" value="0.44" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Bulbar Hyperemia</title>
        <description>Assessed using slit lamp with white light, low-medium magnification 0-4 ( 4= Severe)</description>
        <time_frame>Up to 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Solution</title>
            <description>A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.</description>
          </group>
          <group group_id="O2">
            <title>Control Solution</title>
            <description>A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.</description>
          </group>
        </group_list>
        <measure>
          <title>Bulbar Hyperemia</title>
          <description>Assessed using slit lamp with white light, low-medium magnification 0-4 ( 4= Severe)</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="122"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.55" spread="0.14"/>
                    <measurement group_id="O2" value="0.55" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Subjects participated in the study for a total duration of 30±4 days. Adverse Event data was collected over a period of approximately 12 weeks from the first participant receiving study product.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Test Solution</title>
          <description>Test solution: A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.</description>
        </group>
        <group group_id="E2">
          <title>Control Solution</title>
          <description>Control solution: A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.</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="125"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Ocular Burning</sub_title>
                <description>Subject reported burning upon insertion of Contact Lens (CL) after using solution overnight. Occurred most mornings, self resolved within a couple minutes.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Solution reaction</sub_title>
                <description>Diffuse punctate stain, grade 1. Very superficial. Extent Grade 3</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="125"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Solution reaction</sub_title>
                <description>After 20 mins wear, lenses clouded over and if subject kept in for another 10 mins, they experienced pain on lower eye lids. Some redness. Pain, cloudiness and redness disappeared after lens removal. Tried on 4 separate days, but same symptom.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Solution induced Corneal staining</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="125"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Left eye sore and painful</sub_title>
                <description>Left eye sore and painful with Contact Lenses in. Some pain, redness and discharge. No photophobia.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="125"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Symptoms requiring action, (a piece of contact lens (foreign body) removed</sub_title>
                <description>A piece of contact lens (foreign body) removed from right upper temporal fornix. Sodium fluorescein instilled - no abrasion or other foreign body remaining. No increased hyperaemia, no lid or eye irritation after lens removed.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Possible reaction to material or solution.</sub_title>
                <description>Woke up in the middle of the night and the eyes felt dry, itchy, burning sensation. Next morning the eyes were bloodshot, and slight discharge in both eyes.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="125"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Viral Stomach Bug</sub_title>
                <description>Puking, Nausea, Fatigue</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="125"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </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 Investigator shall not disclose to others any information relating to the study without written authorisation from the Sponsor.&#xD;
All data and discoveries arising out of the Study, patentable or non-patentable, shall be the sole property of the Sponsor or its designated affiliate.&#xD;
The Investigator shall agree to obtain the Sponsor's written consent before discussing, presenting or publicising any pre-clinical and/or clinical data or impressions.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Mr Thomas Boyes, Clinical Project Manager</name_or_title>
      <organization>Visioncare Research Ltd.</organization>
      <phone>+441252 718719 ext 223</phone>
      <email>t.boyes@visioncare.co.uk</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/NCT03278223
org study id: OTES-3301
nct id: NCT03278223
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The purpose of this study is to evaluate the clinical performance of the contact lens care
      product Oté Sensation in a representative population of soft contact lens wearers. For
      comparison, a widely used FDA approved soft lens multipurpose solution will be used as a
      control. This control product has been tested in previous clinical trials.
This will be a 1-month, 200-subject, double-masked (care product), bilateral, randomized,
      comparative study. Subjects will be clinically evaluated at the initial baseline visit (Visit
      1), then after 1 week and 1 month of lens wear having been randomly assigned to use one of
      six lens types and to either the test or control solutions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Comfort
time frame: Up to 4 weeks
description: Subjective comfort(during the day). Subject grading comfort of lenses 0-10 (Higher scores indicates the subjects greater comfort with the lenses.)
measure: Visual Acuity (VA)
time frame: Visual Acuity was assessed for all participants after 2 weeks from day of dispensing lens solution and then again at the final evaluation at the 1 month visit.
description: Monocular and binocular high contrast Visual Acuity (VA) was measured at each visit and evaluated using a LogMAR VA Chart where the size of the letters become increasingly smaller from the top of the chart to the bottom of the chart. On this scale, the minimum VA (Worst achievable) is +1.00 LogMAR and the maximum value (Best achievable) is -0.30 LogMAR. Each line of the chart (a total of five letters per line) is equivalent to -0.10 LogMAR and each letter read is equivalent to -0.02. The lower the score/measurement , indicate a better VA obtained. Participants were positioned at a distance of three meters from the eye chart and asked to start reading letters from the top line and to continuing reading letters until they are unable to correctly identify three letters on any given line. The Visual Acuity was recorded to the nearest letter.
measure: Lens Surface Wetting
time frame: Up to 4 weeks
description: Lens surface wettability rated on the appearance of the lens surface and the drying time viewed with a slit lamp under low magnification. 0-4 scale (4 = Excellent)
measure: Film Deposits
time frame: Up to 4 weeks
description: Any film deposits (protein/lipid) attached to the front surface of the lens. Scan the entire lens surface (10- 20X) for the presence of deposits. 0-4 (4= Heavy film)
measure: Corneal Staining
time frame: Up to 4 weeks
description: Assessed using a slit lamp by sector with fluorescein, blue light, yellow filter and full beam using a medium magnification. Cornea staining will be assessed by sector (Central, Nasal, Temporal, Inferior, Superior) using a 0-4 scale where 0-4 is the total corneal staining score and higher staining score indicates a worse outcome.
measure: Limbal Hyperemia
time frame: Up to 4 weeks
description: Assessed using slit lamp with white light, low-medium magnification. 0-4 ( 4= Severe)
measure: Bulbar Hyperemia
time frame: Up to 4 weeks
description: Assessed using slit lamp with white light, low-medium magnification 0-4 ( 4= Severe)
arm group label: Test solution
arm group type: Active Comparator
description: A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.
arm group label: Control solution
arm group type: Active Comparator
description: A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.
intervention type: Device
intervention name: Test solution
description: A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.
arm group label: Test solution
intervention type: Device
intervention name: Control solution
description: A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.
arm group label: Control solution
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Frances L Nicklin, Bsc, MCOptom
role: Principal Investigator
affiliation: Visioncare Research Ltd.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Hyperopia
mesh term: Pharmaceutical Solutions
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 