<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/NCT03305484</url>
  </required_header>
  <id_info>
    <org_study_id>SCCO-16-15</org_study_id>
    <secondary_id>IIT#23485303</secondary_id>
    <nct_id>NCT03305484</nct_id>
  </id_info>
  <brief_title>Soft Contacts Observation of Risk and Education (SCORE)</brief_title>
  <acronym>SCORE</acronym>
  <official_title>Contact Lens Assessment in Youth - Soft Contacts Observation of Risk and Education (CLAY-SCORE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southern California College of Optometry at Marshall B. Ketchum University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Houston</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>New England College of Optometry</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Waterloo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pacific University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nova Southeastern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Alcon Research</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Southern California College of Optometry at Marshall B. Ketchum University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Specific Aims&#xD;
&#xD;
        1. Develop risk assessment scores for SCL wearers&#xD;
&#xD;
        2. Test the scoring algorithm in SCL wearers who present with adverse events&#xD;
&#xD;
        3. Explore targeted patient education to reduce risk behaviors associated with SCL wear.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a multi-center, case-control prospective study. Subjects will be enrolled at&#xD;
      five geographically diverse locations across North America. The intent is to enroll cases&#xD;
      with new (untreated) red eyes and controls that are representative of the contact lens&#xD;
      wearing population and test the new scoring algorithm on this population.&#xD;
&#xD;
      A total of 232 participants are expected to complete the study (116 case-control sets).&#xD;
      Enrollment will be competitive. After consent, subjects will complete the Contact Lens Risk&#xD;
      Survey (CLRS) online at www.claystudy.org. Data related to symptoms, medical history and&#xD;
      anterior segment evaluation will be collected. Subjects will be treated as usual and&#xD;
      customary by the investigator. No intervention of treatment in this study. Subjects will be&#xD;
      asked to repeat the CLRS at one and six months post initial visit.&#xD;
&#xD;
      Initial factor analysis from the previous CLRS data were used to develop and test the CLRS&#xD;
      algorithm. Five sub-scales were identified in the areas of contact lens care, contact lens&#xD;
      dependence, hygiene, living arrangements and wellness. Assuming a 10% missing data rate, a&#xD;
      total of 58 SCL wearers with &quot;serious and significant&quot; red eye events will allow for&#xD;
      detection of 0.4 or larger effect size.&#xD;
&#xD;
      There are multiple steps to &quot;compliant wear&quot; of contact lenses and while many patients do&#xD;
      many of the correct wear behaviors, it's not realistic for practitioners to re-educate all&#xD;
      wearers on all of the steps necessary to successfully wear SCLs. The CLRS allows patients to&#xD;
      quickly report their specific wear behaviors and then receive only the targeted information&#xD;
      on which behaviors they are doing that puts them at higher risk. A previous CLAY study&#xD;
      demonstrated good repeatability of the CLRS survey one week after initial fielding.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 30, 2017</start_date>
  <completion_date type="Actual">April 16, 2019</completion_date>
  <primary_completion_date type="Actual">October 16, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Validation of the Contact Lens Risk Survey (CLRS)</measure>
    <time_frame>twelve months</time_frame>
    <description>This study will further validate the CORS and facilitate its translation into clinical practice. A scoring algorithm will be developed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Targeted Patient Education</measure>
    <time_frame>twelve months</time_frame>
    <description>Scripted patient education will be generated based on the results of the Contact Lens Risk Survey (CLRS) to determine if changes in behavior at the one and six month time point</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">171</enrollment>
  <condition>Contact Lens Complication</condition>
  <condition>Contact Lens Acute Red Eye</condition>
  <condition>Contact Lens Related Corneal Infiltrate (Disorder)</condition>
  <condition>Contact Lens-Induced Corneal Fluorescein Staining</condition>
  <arm_group>
    <arm_group_label>Symptomatic Contact Lens Wearers</arm_group_label>
    <description>Contact lens wearers who present to the eye care practitioner's office with a symptomatic red eye</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention, observation only</description>
    <arm_group_label>Symptomatic Contact Lens Wearers</arm_group_label>
    <other_name>No intervention, observation only</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 232 participants are expected to complete the study (116 case-control sets).&#xD;
        Enrollment will be competitive; with each of five geographic locations in the United States&#xD;
        and Canada enrolling approximately 24, but no more than 29 case-control sets until the&#xD;
        total sample size of is achieved.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CASES&#xD;
&#xD;
               -  Current SCL wear (as defined by having worn lenses in previous week) without&#xD;
                  restriction on lens material, design, indication, wearing schedule or lens power&#xD;
&#xD;
               -  18 - 39 years of age&#xD;
&#xD;
               -  New (untreated) symptomatic red eye CONTROLS&#xD;
&#xD;
               -  Current SCL wear (as defined by having worn lenses in previous week) without&#xD;
                  restriction on lens material, design, indication, wearing schedule or lens power&#xD;
&#xD;
               -  18 - 39 years of age and gender and age-matched (± 3 years) to Case&#xD;
&#xD;
               -  Have not had an eye care examination within the past three months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CASES&#xD;
&#xD;
               -  Faculty, staff or student at an optometry college or school&#xD;
&#xD;
               -  Family or household member of an eye care provider, ophthalmic technician,&#xD;
                  ophthalmology or optometry residents or optometry students&#xD;
&#xD;
               -  Pregnancy (by self-report)&#xD;
&#xD;
               -  Currently enrolled in another eye/vision clinical trial&#xD;
&#xD;
               -  Previous participant in a CLAY study&#xD;
&#xD;
               -  Wearing SCL in conjunction with gas permeable (GP) lenses (i.e., piggyback&#xD;
                  design, hybrid lens.) CONTROLS&#xD;
&#xD;
               -  Same exclusion criteria as cases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Dawn Lam</last_name>
    <role>Principal Investigator</role>
    <affiliation>Marshall B. Ketchum University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Marshall B. Ketchum University</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92831</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nova Southeastern University College of Optometry</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State, College of Optometry</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Houston, College of Optometry</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Waterloo, Optometry and Vision Science</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <zip>N2L 3G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>September 17, 2019</last_update_submitted>
  <last_update_submitted_qc>September 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southern California College of Optometry at Marshall B. Ketchum University</investigator_affiliation>
    <investigator_full_name>Dawn Lam, MSc, OD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>contact lenses</keyword>
  <keyword>red eye</keyword>
  <keyword>corneal infiltrate</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plans to share IPD</ipd_description>
  </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/NCT03305484
org study id: SCCO-16-15
secondary id: IIT#23485303
nct id: NCT03305484
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Specific Aims

        1. Develop risk assessment scores for SCL wearers

        2. Test the scoring algorithm in SCL wearers who present with adverse events

        3. Explore targeted patient education to reduce risk behaviors associated with SCL wear.
This will be a multi-center, case-control prospective study. Subjects will be enrolled at
      five geographically diverse locations across North America. The intent is to enroll cases
      with new (untreated) red eyes and controls that are representative of the contact lens
      wearing population and test the new scoring algorithm on this population.

      A total of 232 participants are expected to complete the study (116 case-control sets).
      Enrollment will be competitive. After consent, subjects will complete the Contact Lens Risk
      Survey (CLRS) online at www.claystudy.org. Data related to symptoms, medical history and
      anterior segment evaluation will be collected. Subjects will be treated as usual and
      customary by the investigator. No intervention of treatment in this study. Subjects will be
      asked to repeat the CLRS at one and six months post initial visit.

      Initial factor analysis from the previous CLRS data were used to develop and test the CLRS
      algorithm. Five sub-scales were identified in the areas of contact lens care, contact lens
      dependence, hygiene, living arrangements and wellness. Assuming a 10% missing data rate, a
      total of 58 SCL wearers with "serious and significant" red eye events will allow for
      detection of 0.4 or larger effect size.

      There are multiple steps to "compliant wear" of contact lenses and while many patients do
      many of the correct wear behaviors, it's not realistic for practitioners to re-educate all
      wearers on all of the steps necessary to successfully wear SCLs. The CLRS allows patients to
      quickly report their specific wear behaviors and then receive only the targeted information
      on which behaviors they are doing that puts them at higher risk. A previous CLAY study
      demonstrated good repeatability of the CLRS survey one week after initial fielding.
observational model: Case-Control
time perspective: Prospective
measure: Validation of the Contact Lens Risk Survey (CLRS)
time frame: twelve months
description: This study will further validate the CORS and facilitate its translation into clinical practice. A scoring algorithm will be developed.
measure: Targeted Patient Education
time frame: twelve months
description: Scripted patient education will be generated based on the results of the Contact Lens Risk Survey (CLRS) to determine if changes in behavior at the one and six month time point
arm group label: Symptomatic Contact Lens Wearers
description: Contact lens wearers who present to the eye care practitioner's office with a symptomatic red eye
intervention type: Other
intervention name: No intervention
description: No intervention, observation only
arm group label: Symptomatic Contact Lens Wearers
other name: No intervention, observation only
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 39 Years
last name: Dawn Lam
role: Principal Investigator
affiliation: Marshall B. Ketchum University
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Principal Investigator
investigator affiliation: Southern California College of Optometry at Marshall B. Ketchum University
investigator full name: Dawn Lam, MSc, OD
investigator title: Associate Professor
sharing ipd: No
ipd description: No plans to share IPD