<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/NCT04464044</url>
  </required_header>
  <id_info>
    <org_study_id>CLA306-C003</org_study_id>
    <nct_id>NCT04464044</nct_id>
  </id_info>
  <brief_title>Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens</brief_title>
  <official_title>Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to obtain on-eye clinical performance data to evaluate the&#xD;
      stability of axis orientation of DDT2 toric contact lenses in the intended population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-visit, non-dispense study where subjects will be exposed to the test lenses&#xD;
      for approximately 1 hour.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">August 6, 2020</completion_date>
  <primary_completion_date type="Actual">August 6, 2020</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of lenses with axis orientation within ±30° from the intended axis, 10 minutes after lens insertion</measure>
    <time_frame>Day 1, 10 minutes after lens insertion</time_frame>
    <description>Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Astigmatism</condition>
  <arm_group>
    <arm_group_label>DDT2 Toric</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Verofilcon A toric contact lenses worn in both eyes</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>verofilcon A toric contact lenses</intervention_name>
    <description>Daily disposable toric soft contact lenses</description>
    <arm_group_label>DDT2 Toric</arm_group_label>
    <other_name>DDT2 Toric</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to understand and sign an informed consent form;&#xD;
&#xD;
          -  Successful wear of spherical or toric soft contact lenses in both eyes, as specified&#xD;
             in the protocol;&#xD;
&#xD;
          -  Willing to NOT use rewetting/lubricating drops at any time during the study;&#xD;
&#xD;
          -  Other protocol-specified inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any eye condition that would contraindicate contact lens wear, as determined by the&#xD;
             Investigator;&#xD;
&#xD;
          -  History of eye surgery within the previous 12 months, as specified in the protocol;&#xD;
&#xD;
          -  Current or history of dry eye in either eye that, in the opinion of the Investigator,&#xD;
             would preclude contact lens wear;&#xD;
&#xD;
          -  Other protocol-specified exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trial Lead, Vision Care</last_name>
    <role>Study Director</role>
    <affiliation>Alcon Research, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Contact Alcon Call Center for Trial Locations</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>August 18, 2020</last_update_submitted>
  <last_update_submitted_qc>August 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Toric contact lens</keyword>
  <keyword>Daily disposable</keyword>
  <keyword>Silicone hydrogel contact lens</keyword>
  <keyword>Axis orientation</keyword>
  <keyword>Astigmatism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Astigmatism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04464044
org study id: CLA306-C003
nct id: NCT04464044
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to obtain on-eye clinical performance data to evaluate the
      stability of axis orientation of DDT2 toric contact lenses in the intended population.
This is a single-visit, non-dispense study where subjects will be exposed to the test lenses
      for approximately 1 hour.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Percent of lenses with axis orientation within ±30° from the intended axis, 10 minutes after lens insertion
time frame: Day 1, 10 minutes after lens insertion
description: Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis.
arm group label: DDT2 Toric
arm group type: Experimental
description: Verofilcon A toric contact lenses worn in both eyes
intervention type: Device
intervention name: verofilcon A toric contact lenses
description: Daily disposable toric soft contact lenses
arm group label: DDT2 Toric
other name: DDT2 Toric
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trial Lead, Vision Care
role: Study Director
affiliation: Alcon Research, LLC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Astigmatism
sharing ipd: No