<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/NCT02985827</url>
  </required_header>
  <id_info>
    <org_study_id>Menthol FLIR</org_study_id>
    <nct_id>NCT02985827</nct_id>
  </id_info>
  <brief_title>Symptom Response in Normal and Dry Eye Patients Secondary to Application of a Menthol-Containing Eyedrop (Rohto® Hydra)</brief_title>
  <official_title>An Open-Label, Single-Center Study to Evaluate Symptom Response and Tear Film Cooling Dynamics of Normal and Dry Eye Patients Secondary to Application of a Menthol-Containing Eyedrop (Rohto® Hydra)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ORA, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ORA, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to analyze the sensation to eye drops containing menthol in&#xD;
      people with healthy eyes and in people with dry eyes. This study also examines the&#xD;
      temperature of your eye using an Infrared Camera.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dry eye disease (DED) has been defined as a multifactorial disease of the tears and ocular&#xD;
      surface that results in symptoms of discomfort, visual disturbance, and tear film instability&#xD;
      with potential damage to the ocular surface. It is accompanied by increased osmolarity of the&#xD;
      tear film and inflammation of the ocular surface1. An estimated 25 million Americans are&#xD;
      reported to have dry eye disease (DED)2, which is a number that will only increase with the&#xD;
      U.S. aging population3. The only treatment currently available in the U.S. targets&#xD;
      inflammation on the ocular surface. Because dry eye is a complicated disease that encompasses&#xD;
      many conditions of the eye, diversified ways to treating the disease are necessary. Some&#xD;
      recent studies suggests that some Dry Eye symptoms are caused by corneal cold thermoreceptors&#xD;
      (such as TRPM8) chronically firing at below-normal thresholds. It thus logically follows that&#xD;
      dry eye patients could be distinguished from normal patients by possessing higher symptom&#xD;
      responses secondary to topical application of menthol, a potent agonist of TRPM8. If dry eye&#xD;
      patients indeed have lower threshold firing of TRPM8, agonizing TRPM8 with menthol will&#xD;
      elicit a more severe symptom response, given equal concentrations across populations.&#xD;
&#xD;
      To fully elucidate this relationship between TRPM8 agonists, sensation, and tear film&#xD;
      cooling, two dry eye populations will be tested - one population which has exhibited symptom&#xD;
      response to a previous dry eye agent, and one population with no symptom response to the same&#xD;
      agent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2015</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sum of the Cooling Scale For Rohto (r) Hydra</measure>
    <time_frame>4 Minutes</time_frame>
    <description>Participants completed the cooling scale after receiving 1 dose of Rohto (r) Hydra at 6 time points (0, 0.5, 1, 2, 3, and 4 minutes post-treatment), and the scores were summed across these time points. The cooling scale was on a scale of 0 to 10, where 0=not cool and 10=very cool. The summed total was on a scale of 0= not cool and 60=very cool.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sum of the Cooling Scale For Systane (r) Ultra</measure>
    <time_frame>4 minutes</time_frame>
    <description>Participants completed the cooling scale after receiving 1 dose of Systane (r) Ultra at 6 time points (0, 0.5, 1, 2, 3, and 4 minutes post-treatment), and the scores were summed across these time points. The cooling scale was on a scale of 0 to 10, where 0=not cool and 10=very cool. The summed total was on a scale of 0= not cool and 60=very cool.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Dry Eye</condition>
  <arm_group>
    <arm_group_label>Rohto (r) Hydra</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Menthol containing over the counter eyedrop</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Systane (r) Ultra</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Non-Menthol containing over the counter eyedrop</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rohto (r) Hydra</intervention_name>
    <description>Rohto (r) Hydra; Over the counter Eyedrop, 1 gtt OU single-masked in-office dose</description>
    <arm_group_label>Rohto (r) Hydra</arm_group_label>
    <arm_group_label>Systane (r) Ultra</arm_group_label>
    <other_name>Rohto Hydra</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Systane (r) Ultra</intervention_name>
    <description>Systane (r) Ultra; Over the counter Eyedrop, 1 gtt OU single-masked in-office dose</description>
    <arm_group_label>Rohto (r) Hydra</arm_group_label>
    <arm_group_label>Systane (r) Ultra</arm_group_label>
    <other_name>Systane Ultra</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Be male or female of any race, at least 18 years of age at Visit 1.&#xD;
&#xD;
          2. Have provided verbal and written informed consent.&#xD;
&#xD;
          3. Have a best corrected visual acuity of +0.70 logMAR or better in both eyes at Visit 1,&#xD;
             as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.&#xD;
&#xD;
          4. Qualify for exactly one of the three cohorts.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have any contraindications to the use of Systane® Ultra, or Rohto® Hyrda, or its&#xD;
             components (including Menthol).&#xD;
&#xD;
          2. Have a known allergy to the study medications or their components.&#xD;
&#xD;
          3. Have any clinically significant slit lamp findings at Visit 1, including active&#xD;
             blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or ocular&#xD;
             allergies that requires therapeutic treatment and/or, in the opinion of the&#xD;
             investigator, may interfere with the study parameters.&#xD;
&#xD;
          4. Be diagnosed with an ongoing ocular infection (bacterial, viral or fungal), or active&#xD;
             ocular inflammation (e.g., follicular conjunctivitis) at Visit 1.&#xD;
&#xD;
          5. Have a history of laser in situ keratomileusis (LASIK) surgery in either eye.&#xD;
&#xD;
          6. Have had any ocular surgical procedure within 12 months prior to Visit 1.&#xD;
&#xD;
          7. Have used contact lenses within 30 days prior to Visit 1 and for the duration of the&#xD;
             study.&#xD;
&#xD;
          8. Have used any topical ocular prescription (including medications for glaucoma) or&#xD;
             over-the-counter (OTC) solutions, artificial tear substitutes, gels or scrubs within&#xD;
             24 hours prior to Visit 1 and for the duration of the study, except for the study&#xD;
             drops.&#xD;
&#xD;
          9. Have an uncontrolled systemic disease.&#xD;
&#xD;
         10. Be a woman who is pregnant, nursing an infant, or planning a pregnancy.&#xD;
&#xD;
         11. Have a condition or is in a situation that, in the opinion of the investigator, may&#xD;
             put the patient at significant risk, may confound the study results, or may interfere&#xD;
             significantly with the patients' participation in the study.&#xD;
&#xD;
         12. Be currently enrolled in an investigational drug or device study or have used an&#xD;
             investigational drug or device within 30 days prior to Visit 1.&#xD;
&#xD;
         13. Currently have any punctal occlusions in either eye.&#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>
  <overall_official>
    <last_name>Keith Lane</last_name>
    <role>Study Director</role>
    <affiliation>Ora Clinical</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <results_first_submitted>November 27, 2018</results_first_submitted>
  <results_first_submitted_qc>November 27, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 19, 2018</results_first_posted>
  <last_update_submitted>June 23, 2023</last_update_submitted>
  <last_update_submitted_qc>June 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Dry Eye Participants</title>
          <description>Participants with dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol, in the other.</description>
        </group>
        <group group_id="P2">
          <title>Normal Participants</title>
          <description>Participants who did not have dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol, in the other.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Dry Eye Participants</title>
          <description>Participants with dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol, in the other.</description>
        </group>
        <group group_id="B2">
          <title>Normal Participants</title>
          <description>Participants who did not have dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol, in the other.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="33"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="48"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.2" spread="8.6"/>
                    <measurement group_id="B2" value="53.5" spread="7.6"/>
                    <measurement group_id="B3" value="58.4" spread="9.6"/>
                  </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="24"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Sum of the Cooling Scale For Rohto (r) Hydra</title>
        <description>Participants completed the cooling scale after receiving 1 dose of Rohto (r) Hydra at 6 time points (0, 0.5, 1, 2, 3, and 4 minutes post-treatment), and the scores were summed across these time points. The cooling scale was on a scale of 0 to 10, where 0=not cool and 10=very cool. The summed total was on a scale of 0= not cool and 60=very cool.</description>
        <time_frame>4 Minutes</time_frame>
        <population>All Participants Population- all participants who received both study treatments.</population>
        <group_list>
          <group group_id="O1">
            <title>Dry Eye Participants</title>
            <description>Participants with dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol, in the other.</description>
          </group>
          <group group_id="O2">
            <title>Normal Participants</title>
            <description>Participants who did not have dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol, in the other.</description>
          </group>
        </group_list>
        <measure>
          <title>Sum of the Cooling Scale For Rohto (r) Hydra</title>
          <description>Participants completed the cooling scale after receiving 1 dose of Rohto (r) Hydra at 6 time points (0, 0.5, 1, 2, 3, and 4 minutes post-treatment), and the scores were summed across these time points. The cooling scale was on a scale of 0 to 10, where 0=not cool and 10=very cool. The summed total was on a scale of 0= not cool and 60=very cool.</description>
          <population>All Participants Population- all participants who received both study treatments.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.6" spread="12.2"/>
                    <measurement group_id="O2" value="12.1" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sum of the Cooling Scale For Systane (r) Ultra</title>
        <description>Participants completed the cooling scale after receiving 1 dose of Systane (r) Ultra at 6 time points (0, 0.5, 1, 2, 3, and 4 minutes post-treatment), and the scores were summed across these time points. The cooling scale was on a scale of 0 to 10, where 0=not cool and 10=very cool. The summed total was on a scale of 0= not cool and 60=very cool.</description>
        <time_frame>4 minutes</time_frame>
        <population>All Participants Population- all participants who received both study treatments.</population>
        <group_list>
          <group group_id="O1">
            <title>Dry Eye Participants</title>
            <description>Participants with dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol, in the other.</description>
          </group>
          <group group_id="O2">
            <title>Normal Participants</title>
            <description>Participants who did not have dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol, in the other.</description>
          </group>
        </group_list>
        <measure>
          <title>Sum of the Cooling Scale For Systane (r) Ultra</title>
          <description>Participants completed the cooling scale after receiving 1 dose of Systane (r) Ultra at 6 time points (0, 0.5, 1, 2, 3, and 4 minutes post-treatment), and the scores were summed across these time points. The cooling scale was on a scale of 0 to 10, where 0=not cool and 10=very cool. The summed total was on a scale of 0= not cool and 60=very cool.</description>
          <population>All Participants Population- all participants who received both study treatments.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.6" spread="9.4"/>
                    <measurement group_id="O2" value="5.2" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from the signing of the informed consent form to the end of the study, approximately 1 month.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Dry Eye Participants</title>
          <description>Participants with dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol.</description>
        </group>
        <group group_id="E2">
          <title>Normal Participants</title>
          <description>Participants who did not have dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </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="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Director of Research and Development</name_or_title>
      <organization>Ora</organization>
      <phone>9786858900</phone>
      <email>klane@oraclinical.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/NCT02985827
org study id: Menthol FLIR
nct id: NCT02985827
lead sponsor: 
has dmc: No
The purpose of the study is to analyze the sensation to eye drops containing menthol in
      people with healthy eyes and in people with dry eyes. This study also examines the
      temperature of your eye using an Infrared Camera.
Dry eye disease (DED) has been defined as a multifactorial disease of the tears and ocular
      surface that results in symptoms of discomfort, visual disturbance, and tear film instability
      with potential damage to the ocular surface. It is accompanied by increased osmolarity of the
      tear film and inflammation of the ocular surface1. An estimated 25 million Americans are
      reported to have dry eye disease (DED)2, which is a number that will only increase with the
      U.S. aging population3. The only treatment currently available in the U.S. targets
      inflammation on the ocular surface. Because dry eye is a complicated disease that encompasses
      many conditions of the eye, diversified ways to treating the disease are necessary. Some
      recent studies suggests that some Dry Eye symptoms are caused by corneal cold thermoreceptors
      (such as TRPM8) chronically firing at below-normal thresholds. It thus logically follows that
      dry eye patients could be distinguished from normal patients by possessing higher symptom
      responses secondary to topical application of menthol, a potent agonist of TRPM8. If dry eye
      patients indeed have lower threshold firing of TRPM8, agonizing TRPM8 with menthol will
      elicit a more severe symptom response, given equal concentrations across populations.

      To fully elucidate this relationship between TRPM8 agonists, sensation, and tear film
      cooling, two dry eye populations will be tested - one population which has exhibited symptom
      response to a previous dry eye agent, and one population with no symptom response to the same
      agent.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Sum of the Cooling Scale For Rohto (r) Hydra
time frame: 4 Minutes
description: Participants completed the cooling scale after receiving 1 dose of Rohto (r) Hydra at 6 time points (0, 0.5, 1, 2, 3, and 4 minutes post-treatment), and the scores were summed across these time points. The cooling scale was on a scale of 0 to 10, where 0=not cool and 10=very cool. The summed total was on a scale of 0= not cool and 60=very cool.
measure: Sum of the Cooling Scale For Systane (r) Ultra
time frame: 4 minutes
description: Participants completed the cooling scale after receiving 1 dose of Systane (r) Ultra at 6 time points (0, 0.5, 1, 2, 3, and 4 minutes post-treatment), and the scores were summed across these time points. The cooling scale was on a scale of 0 to 10, where 0=not cool and 10=very cool. The summed total was on a scale of 0= not cool and 60=very cool.
arm group label: Rohto (r) Hydra
arm group type: Active Comparator
description: Menthol containing over the counter eyedrop
arm group label: Systane (r) Ultra
arm group type: Placebo Comparator
description: Non-Menthol containing over the counter eyedrop
intervention type: Drug
intervention name: Rohto (r) Hydra
description: Rohto (r) Hydra; Over the counter Eyedrop, 1 gtt OU single-masked in-office dose
arm group label: Rohto (r) Hydra
arm group label: Systane (r) Ultra
other name: Rohto Hydra
intervention type: Drug
intervention name: Systane (r) Ultra
description: Systane (r) Ultra; Over the counter Eyedrop, 1 gtt OU single-masked in-office dose
arm group label: Rohto (r) Hydra
arm group label: Systane (r) Ultra
other name: Systane Ultra
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Keith Lane
role: Study Director
affiliation: Ora Clinical
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 