<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/NCT02186431</url>
  </required_header>
  <id_info>
    <org_study_id>CLIK_601933</org_study_id>
    <nct_id>NCT02186431</nct_id>
  </id_info>
  <brief_title>Contact Lenses and Infiltrative Keratitis</brief_title>
  <acronym>CLIK</acronym>
  <official_title>Contact Lenses and Infiltrative Keratitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State University of New York College of Optometry</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>State University of New York College of Optometry</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To quantify and compare baseline tear proteins and ocular response in contact lens wearers&#xD;
      with a history of corneal infiltrative events, to those without a history of complications.&#xD;
      This will be accomplished via measurement of select anti-inflammatory tear proteins before,&#xD;
      during and after contact lens wear.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tear protein levels</measure>
    <time_frame>After 4-6 hours of daily wear and after one night extended wear</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Keratitis</condition>
  <arm_group>
    <arm_group_label>history of corneal infiltrative events</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To quantify and compare baseline tear proteins and ocular response in contact lens wearers with a history of corneal infiltrative events</description>
  </arm_group>
  <arm_group>
    <arm_group_label>without a history of corneal infiltrative events</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>To quantify and compare baseline tear proteins and ocular response in contact lens wearers without a history of corneal infiltrative events.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>senofilcon A</intervention_name>
    <arm_group_label>history of corneal infiltrative events</arm_group_label>
    <arm_group_label>without a history of corneal infiltrative events</arm_group_label>
    <other_name>Acuvue Oasys</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Soft contact lens wearers&#xD;
&#xD;
          -  Healthy (control), or with history of infiltrative keratitis (case)&#xD;
&#xD;
          -  Has a wearable pair of glasses&#xD;
&#xD;
          -  Refractive error between +8.00 D and -12.00 D, with less than 1.50 D of astigmatism&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoker&#xD;
&#xD;
          -  Pregnant or nursing&#xD;
&#xD;
          -  Systemic disease that would effect tear proteins&#xD;
&#xD;
          -  Punctal plugs&#xD;
&#xD;
          -  Use of eye drops in the last week&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathryn Richdale, OD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>State University of New York College of Optometry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SUNY College of Optometry, Clinical Vision Research Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>July 8, 2016</last_update_submitted>
  <last_update_submitted_qc>July 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>State University of New York College of Optometry</investigator_affiliation>
    <investigator_full_name>Kathryn Richdale</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Contact lenses</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Keratitis</mesh_term>
  </condition_browse>
  <!-- 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/NCT02186431
org study id: CLIK_601933
nct id: NCT02186431
lead sponsor: 
has dmc: No
To quantify and compare baseline tear proteins and ocular response in contact lens wearers
      with a history of corneal infiltrative events, to those without a history of complications.
      This will be accomplished via measurement of select anti-inflammatory tear proteins before,
      during and after contact lens wear.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Tear protein levels
time frame: After 4-6 hours of daily wear and after one night extended wear
arm group label: history of corneal infiltrative events
arm group type: Experimental
description: To quantify and compare baseline tear proteins and ocular response in contact lens wearers with a history of corneal infiltrative events
arm group label: without a history of corneal infiltrative events
arm group type: Active Comparator
description: To quantify and compare baseline tear proteins and ocular response in contact lens wearers without a history of corneal infiltrative events.
intervention type: Device
intervention name: senofilcon A
arm group label: history of corneal infiltrative events
arm group label: without a history of corneal infiltrative events
other name: Acuvue Oasys
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kathryn Richdale, OD, PhD
role: Principal Investigator
affiliation: State University of New York College of Optometry
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: State University of New York College of Optometry
investigator full name: Kathryn Richdale
investigator title: Assistant Professor
mesh term: Keratitis