<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/NCT02258139</url>
  </required_header>
  <id_info>
    <org_study_id>14-002</org_study_id>
    <nct_id>NCT02258139</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens</brief_title>
  <official_title>The Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bausch &amp; Lomb Incorporated</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bausch &amp; Lomb Incorporated</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be a randomized non-dispensing study comparing the overnight corneal swelling of an&#xD;
      eye while wearing no contact lens to the Ultra contract lens.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 3, 2014</start_date>
  <completion_date type="Actual">December 11, 2014</completion_date>
  <primary_completion_date type="Actual">December 11, 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change in Central Corneal Thickness</measure>
    <time_frame>8 hours</time_frame>
    <description>Percent change in central corneal thickness from evening to morning (after 8 hours with lid closed)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Restore Central Corneal Thickness</measure>
    <time_frame>48 hours</time_frame>
    <description>Time (hours) to restore central corneal thickness to its baseline value after lens removal</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Corneal Deformity</condition>
  <arm_group>
    <arm_group_label>Study Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B&amp;L Investigational Contact Lens</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>B&amp;L Investigational Contact Lens</intervention_name>
    <description>The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens.</description>
    <arm_group_label>Study Group 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be between 18 and 40 years of age (inclusive)&#xD;
&#xD;
          -  Not a current contact lens wearer (have not worn extended wear, and not worn in lenses&#xD;
             in 6 months)&#xD;
&#xD;
          -  Able to read, comprehend and sign an informed consent&#xD;
&#xD;
          -  Willing to comply with the wear and study visit schedule&#xD;
&#xD;
          -  Monocular best-corrected distance visual acuity &gt;/-20/25 in each eye&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any active corneal infection, disease, injury, inflammation, past surgery, or ocular&#xD;
             abnormality which may interfere with contact lens wear&#xD;
&#xD;
          -  Systemic or ocular allergies, which might interfere with contact lens wear&#xD;
&#xD;
          -  Systemic disease or condition, which might interfere with contact lens wear&#xD;
&#xD;
          -  Use of prescription sleep aids or alcohol within 24 hours of study appointment&#xD;
&#xD;
          -  Inability to wear contact lenses&#xD;
&#xD;
          -  Under 18 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Steffen, OD, MS</last_name>
    <role>Study Director</role>
    <affiliation>Bausch &amp; Lomb Incorporated</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indiana University</name>
      <address>
        <city>Bloomington</city>
        <state>Indiana</state>
        <zip>47405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <results_first_submitted>August 21, 2020</results_first_submitted>
  <results_first_submitted_qc>September 11, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 14, 2020</results_first_posted>
  <last_update_submitted>September 11, 2020</last_update_submitted>
  <last_update_submitted_qc>September 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Study Group 1</title>
          <description>1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B&amp;L Investigational Contact Lens&#xD;
B&amp;L Investigational Contact Lens: The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Study Group 1</title>
          <description>1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B&amp;L Investigational Contact Lens&#xD;
B&amp;L Investigational Contact Lens: The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="38"/>
          </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="21.4" spread="2.8"/>
                  </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="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change in Central Corneal Thickness</title>
        <description>Percent change in central corneal thickness from evening to morning (after 8 hours with lid closed)</description>
        <time_frame>8 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Group 1</title>
            <description>1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B&amp;L Investigational Contact Lens&#xD;
B&amp;L Investigational Contact Lens: The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Central Corneal Thickness</title>
          <description>Percent change in central corneal thickness from evening to morning (after 8 hours with lid closed)</description>
          <units>milimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1 (without lens)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.01" spread="1.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2 (with lens)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.57" spread="2.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Restore Central Corneal Thickness</title>
        <description>Time (hours) to restore central corneal thickness to its baseline value after lens removal</description>
        <time_frame>48 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Eye With Lens</title>
            <description>Test eye after lens removed</description>
          </group>
          <group group_id="O2">
            <title>Control Eye</title>
            <description>Control eye in subjects with lens in test eye</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Restore Central Corneal Thickness</title>
          <description>Time (hours) to restore central corneal thickness to its baseline value after lens removal</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.2"/>
                    <measurement group_id="O2" value="63.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.7"/>
                    <measurement group_id="O2" value="23.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.8"/>
                    <measurement group_id="O2" value="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3"/>
                    <measurement group_id="O2" value="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;4 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 days</time_frame>
      <desc>Adverse events were not coded. Therefore, source vocabulary is not applicable.</desc>
      <group_list>
        <group group_id="E1">
          <title>Study Group 1</title>
          <description>1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B&amp;L Investigational Contact Lens&#xD;
B&amp;L Investigational Contact Lens: The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens.</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="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="38"/>
              </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>Contact sponsor directly for details.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Bausch Health</organization>
      <phone>585-338-6399</phone>
      <email>robert.steffen@bausch.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/NCT02258139
org study id: 14-002
nct id: NCT02258139
lead sponsor: 
has dmc: No
This will be a randomized non-dispensing study comparing the overnight corneal swelling of an
      eye while wearing no contact lens to the Ultra contract lens.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent Change in Central Corneal Thickness
time frame: 8 hours
description: Percent change in central corneal thickness from evening to morning (after 8 hours with lid closed)
measure: Time to Restore Central Corneal Thickness
time frame: 48 hours
description: Time (hours) to restore central corneal thickness to its baseline value after lens removal
arm group label: Study Group 1
arm group type: Experimental
description: 1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B&L Investigational Contact Lens
intervention type: Device
intervention name: B&L Investigational Contact Lens
description: The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens.
arm group label: Study Group 1
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Robert Steffen, OD, MS
role: Study Director
affiliation: Bausch & Lomb Incorporated
facility: 
country: United States
responsible party type: Sponsor
mesh term: Congenital Abnormalities
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 