xml: <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/NCT05992675</url>
    </required_header>
    <id_info>
      <org_study_id>CLD265-N003</org_study_id>
      <nct_id>NCT05992675</nct_id>
    </id_info>
    <brief_title>Air Optix® Night and Day® Aqua Continuous Wear</brief_title>
    <official_title>Air Optix® Night and Day® Aqua Continuous Wear</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this retrospective, Post-Market Clinical Follow-Up (PMCF) study is to assess&#xD;
        the long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses&#xD;
        in a real-world setting when worn as 30 days of continuous wear for vision correction.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a non-interventional/observational study designed as a retrospective chart review.&#xD;
        Study sites will identify charts within their existing databases in a fair and consistent&#xD;
        manner. Subjects/charts meeting the eligibility criteria will be enrolled in the study.&#xD;
  &#xD;
        The study is designed with one period. The duration of the period includes the Baseline Visit&#xD;
        and the Year 3 Visit as follows:&#xD;
  &#xD;
          -  The Baseline Visit is defined as the first office visit where an eye care professional&#xD;
             provided an in-person office biomicroscopy exam to the subject, before or during which a&#xD;
             contact lens prescription for AONDA or PureVision 2 (PV2) was released.&#xD;
  &#xD;
          -  The Year 3 Visit is defined as a visit which occurred 3 years (-2/+8 months) since&#xD;
             Baseline during which period the subject was wearing AONDA contact lenses or PV2 contact&#xD;
             lenses and a contact lens examination was performed.&#xD;
  &#xD;
        The data collection period is defined as any approximately 3-year timeframe since and&#xD;
        including 2009.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Distance visual acuity</measure>
      <time_frame>Year 3</time_frame>
      <description>The subject's chart will be reviewed for distance visual acuity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of corneal infiltrative events</measure>
      <time_frame>Up to Year 3</time_frame>
      <description>The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the Baseline Visit exam.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of microbial keratitis</measure>
      <time_frame>Up to Year 3</time_frame>
      <description>The subject's chart will be reviewed for incidences of microbial keratitis occurring after the Baseline Visit exam.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">1140</enrollment>
    <condition>Refractive Errors</condition>
    <arm_group>
      <arm_group_label>AONDA contact lenses</arm_group_label>
      <description>Lotrafilcon A contact lenses worn in a 30-day, continuous wear modality (lenses worn continuously including overnight) over a period of approximately 3 years</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PV2 contact lenses</arm_group_label>
      <description>Balafilcon A contact lenses worn in a 30-day, continuous wear modality (lenses worn continuously including overnight) over a period of approximately 3 years</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Lotrafilcon A contact lenses</intervention_name>
      <description>CE-marked silicone hydrogel contact lenses</description>
      <arm_group_label>AONDA contact lenses</arm_group_label>
      <other_name>Air Optix® Night and Day® Aqua</other_name>
      <other_name>AONDA</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Balafilcon A contact lenses</intervention_name>
      <description>CE-marked silicone hydrogel contact lenses</description>
      <arm_group_label>PV2 contact lenses</arm_group_label>
      <other_name>PureVision® 2</other_name>
      <other_name>PV2</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Investigators will enroll charts following a pre-identified process.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
            -  Manifest refraction cylinder less than or equal to 0.75 diopter in each eye at&#xD;
               baseline&#xD;
  &#xD;
            -  Best corrected visual acuity of 20/25 or better in each eye at baseline&#xD;
  &#xD;
            -  At the time of Year 3 Visit, subject was prescribed and wearing AONDA or PV2 contact&#xD;
               lenses in both eyes in a 30-day continuous wear modality for at least approximately 3&#xD;
               years&#xD;
  &#xD;
            -  Baseline Visit and Year 3 Visit charts available&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            -  Any recurrent history or active anterior segment infection, inflammation, abnormality,&#xD;
               or disease contraindicating regular contact lens wear present at baseline&#xD;
  &#xD;
            -  The use of systemic or ocular medications contraindicating regular contact lens wear&#xD;
               at baseline&#xD;
  &#xD;
            -  History of refractive surgery or irregular cornea&#xD;
  &#xD;
            -  Slit lamp findings, including signs of pathological dry eye, that would contraindicate&#xD;
               regular contact lens wear at baseline&#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, CRD Vision Care</last_name>
      <role>Study Director</role>
      <affiliation>Alcon Research, LLC</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alcon Call Center</last_name>
      <phone>1-888-451-3937</phone>
      <email>alcon.medinfo@alcon.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Contact Lenses</keyword>
    <keyword>Overnight wear</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Refractive Errors</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05992675
  org study id: CLD265-N003
  nct id: NCT05992675
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  The purpose of this retrospective, Post-Market Clinical Follow-Up (PMCF) study is to assess
        the long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses
        in a real-world setting when worn as 30 days of continuous wear for vision correction.
  This is a non-interventional/observational study designed as a retrospective chart review.
        Study sites will identify charts within their existing databases in a fair and consistent
        manner. Subjects/charts meeting the eligibility criteria will be enrolled in the study.
  
        The study is designed with one period. The duration of the period includes the Baseline Visit
        and the Year 3 Visit as follows:
  
          -  The Baseline Visit is defined as the first office visit where an eye care professional
             provided an in-person office biomicroscopy exam to the subject, before or during which a
             contact lens prescription for AONDA or PureVision 2 (PV2) was released.
  
          -  The Year 3 Visit is defined as a visit which occurred 3 years (-2/+8 months) since
             Baseline during which period the subject was wearing AONDA contact lenses or PV2 contact
             lenses and a contact lens examination was performed.
  
        The data collection period is defined as any approximately 3-year timeframe since and
        including 2009.
  observational model: Cohort
  time perspective: Retrospective
  measure: Distance visual acuity
  time frame: Year 3
  description: The subject's chart will be reviewed for distance visual acuity.
  measure: Incidence of corneal infiltrative events
  time frame: Up to Year 3
  description: The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the Baseline Visit exam.
  measure: Incidence of microbial keratitis
  time frame: Up to Year 3
  description: The subject's chart will be reviewed for incidences of microbial keratitis occurring after the Baseline Visit exam.
  arm group label: AONDA contact lenses
  description: Lotrafilcon A contact lenses worn in a 30-day, continuous wear modality (lenses worn continuously including overnight) over a period of approximately 3 years
  arm group label: PV2 contact lenses
  description: Balafilcon A contact lenses worn in a 30-day, continuous wear modality (lenses worn continuously including overnight) over a period of approximately 3 years
  intervention type: Device
  intervention name: Lotrafilcon A contact lenses
  description: CE-marked silicone hydrogel contact lenses
  arm group label: AONDA contact lenses
  other name: Air Optix® Night and Day® Aqua
  other name: AONDA
  intervention type: Device
  intervention name: Balafilcon A contact lenses
  description: CE-marked silicone hydrogel contact lenses
  arm group label: PV2 contact lenses
  other name: PureVision® 2
  other name: PV2
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Clinical Trial Lead, CRD Vision Care
  role: Study Director
  affiliation: Alcon Research, LLC
  last name: Alcon Call Center
  phone: 1-888-451-3937
  email: alcon.medinfo@alcon.com
  responsible party type: Sponsor
  mesh term: Refractive Errors
  sharing ipd: No