<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/NCT01692964</url>
  </required_header>
  <id_info>
    <org_study_id>12-0615</org_study_id>
    <nct_id>NCT01692964</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of the InflammaDry Device for Detecting Dry Eye</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rapid Pathogen Screening</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RapidPS</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      InflammaDry is a rapid diagnostic test for the detection of elevated levels of Matrix&#xD;
      Metalloproteinase-9 (MMP-9) protein in tear fluid.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The InflammaDry test will be used to aid in the diagnosis of dry eye in conjunction with&#xD;
      other methods of clinical evaluation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Negative and Positive Agreement of the InflammaDry at Diagnosis of Dry Eyes</measure>
    <time_frame>20 minutes</time_frame>
    <description>Negative agreement is the percentage of true negative cases compared to clinical assessment (specificity). Positive agreement is the percentage of true positive cases compared to clinical assessment (sensitivity). The InflammaDry test was compared with the clinical assessment of tear break-up time, Schirmer tear testing, and corneal staining for the confirmation of dry eye, both with and without the inclusion of the Ocular Surface Disease Index (OSDI), as a confirmatory test.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">237</enrollment>
  <condition>Dysfunctional Tear Syndrome</condition>
  <arm_group>
    <arm_group_label>InflammaDry</arm_group_label>
    <description>Patients suspected of having dry eye will be tested with the InflammaDry.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>InflammaDry</intervention_name>
    <description>A noninvasive immunoassay for detecting MMP-9 levels in tears.</description>
    <arm_group_label>InflammaDry</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who were clinically determined by an ophthalmic clinician to meet enrollment&#xD;
        criteria were included in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Patient voluntarily reported at least 1 episode of any of the following ocular&#xD;
             symptoms during the last month:&#xD;
&#xD;
               1. Burning or stinging&#xD;
&#xD;
               2. Sandy or gritty feeling&#xD;
&#xD;
               3. Foreign body sensation&#xD;
&#xD;
               4. Tearing&#xD;
&#xD;
               5. Light sensitivity&#xD;
&#xD;
               6. Intermittent or fluctuating vision&#xD;
&#xD;
               7. Tired eyes&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Allergy to cornstarch or Dacron&#xD;
&#xD;
          -  Allergy to topical anesthetic or fluorescein dye&#xD;
&#xD;
          -  Prior eye injury, trauma, or ocular surgery within the last 3 months&#xD;
&#xD;
          -  Known blockage of the lacrimal drainage system&#xD;
&#xD;
          -  Contact lens wear in the last month&#xD;
&#xD;
          -  Previous corneal refractive surgery including RK, LASIK or PRK surgery&#xD;
&#xD;
          -  Have an active ocular infection or history of a recent ocular infection in the last&#xD;
             month&#xD;
&#xD;
          -  Have active intraocular inflammation or history of intraocular inflammation, e.g.&#xD;
             Uveitis&#xD;
&#xD;
          -  Use of oral doxycycline, corticosteroids, or immunomodulators in the last month&#xD;
&#xD;
          -  Have received topical ocular corticosteroids, topical Nonsteroidal (NSAIDs) therapy,&#xD;
             or topical ocular cyclosporine in the last month&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Use of any topical ophthalmic medications, including artificial tears 2 hours prior to&#xD;
             enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Manatee-Sarasota Eye Clinic</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Clinic - Eye Specialists</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthalmic Associates</name>
      <address>
        <city>Johnson City</city>
        <state>New York</state>
        <zip>13790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthalmology Diagnostics &amp; Clinical Research</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79904-2037</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>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <results_first_submitted>August 13, 2020</results_first_submitted>
  <results_first_submitted_qc>September 18, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 12, 2020</results_first_posted>
  <last_update_submitted>September 18, 2020</last_update_submitted>
  <last_update_submitted_qc>September 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dry Eye</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The recruitment took place over a 7-month period. The study was performed at private practices and academic centers.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>InflammaDry</title>
          <description>Patients suspected of having dry eye will be tested with the InflammaDry.&#xD;
InflammaDry: A noninvasive immunoassay for detecting MMP-9 levels in tears.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="237"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="237"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>InflammaDry</title>
          <description>Patients suspected of having dry eye will be tested with the InflammaDry.&#xD;
InflammaDry: A noninvasive immunoassay for detecting MMP-9 levels in tears.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="237"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53" lower_limit="18" upper_limit="94"/>
                  </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="164"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="237"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Negative and Positive Agreement of the InflammaDry at Diagnosis of Dry Eyes</title>
        <description>Negative agreement is the percentage of true negative cases compared to clinical assessment (specificity). Positive agreement is the percentage of true positive cases compared to clinical assessment (sensitivity). The InflammaDry test was compared with the clinical assessment of tear break-up time, Schirmer tear testing, and corneal staining for the confirmation of dry eye, both with and without the inclusion of the Ocular Surface Disease Index (OSDI), as a confirmatory test.</description>
        <time_frame>20 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>InflammaDry (Sensitivity)</title>
            <description>Looking for the percentage of true positives as compared to clinical assessment.</description>
          </group>
          <group group_id="O2">
            <title>Inflammadry (Specificity)</title>
            <description>Looking for the percentage of true negatives as compared to clinical assessment.</description>
          </group>
        </group_list>
        <measure>
          <title>Negative and Positive Agreement of the InflammaDry at Diagnosis of Dry Eyes</title>
          <description>Negative agreement is the percentage of true negative cases compared to clinical assessment (specificity). Positive agreement is the percentage of true positive cases compared to clinical assessment (sensitivity). The InflammaDry test was compared with the clinical assessment of tear break-up time, Schirmer tear testing, and corneal staining for the confirmation of dry eye, both with and without the inclusion of the Ocular Surface Disease Index (OSDI), as a confirmatory test.</description>
          <units>percentage of cases</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="237"/>
                <count group_id="O2" value="237"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Confirmatory Testing With OSDI Inclusion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81" lower_limit="74" upper_limit="87"/>
                    <measurement group_id="O2" value="98" lower_limit="91" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Confirmatory Testing Without OSDI Inclusion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86" lower_limit="80" upper_limit="91"/>
                    <measurement group_id="O2" value="97" lower_limit="91" upper_limit="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>20 Minutes</time_frame>
      <desc>Regular monitoring by sponsor and mandatory reporting by investigator.</desc>
      <group_list>
        <group group_id="E1">
          <title>InflammaDry</title>
          <description>Patients suspected of having dry eye will be tested with the InflammaDry.&#xD;
InflammaDry: A noninvasive immunoassay for detecting MMP-9 levels in tears.</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="237"/>
              </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="237"/>
              </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>Publications shall be submitted to the Sponsor for review/comment 45 days prior to publication. Sponsor may remove confidential information. First publication shall be a multicenter study publication. Institution and/or PI may publish or present the results and data from the Institution's site individually (i) 12 months after conclusion, abandonment or termination of study at all sites, or (ii) after the Sponsor confirms there will be no multicenter study publication, whichever occurs first.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Robert Sambursky, MD</name_or_title>
      <organization>Rapid Pathogen Screening, Inc.</organization>
      <phone>941-556-1853</phone>
      <email>rob.sambursky@lumosdiagnostics.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/NCT01692964
org study id: 12-0615
nct id: NCT01692964
lead sponsor: 
has dmc: No
InflammaDry is a rapid diagnostic test for the detection of elevated levels of Matrix
      Metalloproteinase-9 (MMP-9) protein in tear fluid.
The InflammaDry test will be used to aid in the diagnosis of dry eye in conjunction with
      other methods of clinical evaluation.
observational model: Cohort
time perspective: Prospective
measure: Negative and Positive Agreement of the InflammaDry at Diagnosis of Dry Eyes
time frame: 20 minutes
description: Negative agreement is the percentage of true negative cases compared to clinical assessment (specificity). Positive agreement is the percentage of true positive cases compared to clinical assessment (sensitivity). The InflammaDry test was compared with the clinical assessment of tear break-up time, Schirmer tear testing, and corneal staining for the confirmation of dry eye, both with and without the inclusion of the Ocular Surface Disease Index (OSDI), as a confirmatory test.
arm group label: InflammaDry
description: Patients suspected of having dry eye will be tested with the InflammaDry.
intervention type: Device
intervention name: InflammaDry
description: A noninvasive immunoassay for detecting MMP-9 levels in tears.
arm group label: InflammaDry
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 