<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/NCT03782701</url>
  </required_header>
  <id_info>
    <org_study_id>20180895</org_study_id>
    <nct_id>NCT03782701</nct_id>
  </id_info>
  <brief_title>The Effect of Lumify™ Eyedrops on Eyelid Position</brief_title>
  <official_title>The Effect of Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) on Palpebral Fissure Height</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the research is to see if Lumify™ has an effect on eyelid position.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 18, 2019</start_date>
  <completion_date type="Actual">April 1, 2020</completion_date>
  <primary_completion_date type="Actual">April 1, 2020</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>Parallel Assignment</intervention_model>
    <intervention_model_description>The left and right eye of each subject will be randomized to receive either Lumify or balanced saline placebo.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Palpebral Fissure Height</measure>
    <time_frame>Baseline, 5, 15 and 30 minutes after application</time_frame>
    <description>Objective measurement of distance between inner margin of upper and lower eyelids from clinical photographs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraocular Pressure</measure>
    <time_frame>Baseline, 5, 15 and 30 minutes after application</time_frame>
    <description>Measurement of intraocular pressure using handheld Tono-Pen(tm) tonometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eye Redness</measure>
    <time_frame>Baseline, 5, 15 and 30 minutes after application</time_frame>
    <description>Eye redness will be reported as the number of participants achieving a score of ocular redness from clinical photographs as 0 (none), 1 (mild), 2 (moderate) and 3 (severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eye Discomfort</measure>
    <time_frame>Baseline, 5, 15 and 30 minutes after application</time_frame>
    <description>Eye discomfort will be reported as the number of participants reporting subjective ocular discomfort score from 0 (none), 1 (mild), 2 (mild) and 3 (severe).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Eyelid Droop</condition>
  <arm_group>
    <arm_group_label>Lumify Eye Drop</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be randomized to receive a single drop of Lumify to either the left or right eye.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline Solution Eye Drop</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be randomized to receive a single drop of sterile balanced saline solution to either the left or right eye.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Brimonidine tartrate ophthalmic solution 0.025%</intervention_name>
    <description>One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface)</description>
    <arm_group_label>Lumify Eye Drop</arm_group_label>
    <other_name>Lumify</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sterile balanced saline solution</intervention_name>
    <description>One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)</description>
    <arm_group_label>Saline Solution Eye Drop</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults age 18 and above able to provide informed consent to participate&#xD;
&#xD;
          -  Subject with stable ocular health, defined as no ocular conditions requiring ongoing&#xD;
             topical therapy or recent surgical intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adults unable to consent&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Pregnant women.&#xD;
&#xD;
          -  Known contradictions or sensitivities to study medication (brimonidine)&#xD;
&#xD;
          -  Ocular surgery within the past 3 months or refractive surgery within the past six&#xD;
             months&#xD;
&#xD;
          -  Grossly abnormal lid margins, anatomical abnormalities, previous eyelid or orbital&#xD;
             surgery&#xD;
&#xD;
          -  Variable ptosis or eyelid position (e.g., myasthenia gravis, thyroid eye disease, or&#xD;
             blepharospasm)&#xD;
&#xD;
          -  Significant pre-existing ptosis of any cause (defined as margin reflex distance 1 &lt;&#xD;
             1mm)&#xD;
&#xD;
          -  Any ocular or systemic condition that, in the opinion of the investigator, would&#xD;
             confound study data, interfere with the subject's study participation, or affected the&#xD;
             subject's safety or trial parameters&#xD;
&#xD;
          -  Presence of an active ocular infection&#xD;
&#xD;
          -  Prior (within 5 days of beginning study treatment) use of eye whiteners (eg,&#xD;
             vasoconstrictors), decongestants, antihistamines (including over the counter and&#xD;
             herbal topical ophthalmic medications), phenylephrine dilating drops, any other&#xD;
             topical ophthalmic agents&#xD;
&#xD;
          -  Inability to sit comfortably for 15 - 30 minutes&#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>Wendy W Lee, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bascom Palmer Eye Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bascom Palmer Eye Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>November 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <results_first_submitted>March 31, 2021</results_first_submitted>
  <results_first_submitted_qc>June 7, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 14, 2021</results_first_posted>
  <last_update_submitted>June 7, 2021</last_update_submitted>
  <last_update_submitted_qc>June 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Wendy Lee</investigator_full_name>
    <investigator_title>Associate Professor of Ophthalmology and Dermatology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Blepharoptosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brimonidine Tartrate</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
    <mesh_term>Ophthalmic Solutions</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 27, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT03782701/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>All Participants</title>
          <description>All participants received both the Lumify and saline solution. The left and right eye of each subject was randomized to receive either Lumify or balanced saline solution.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Lumify</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Saline Solution</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
              </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>All Participants</title>
          <description>All participants received both the Lumify and saline solution. The left and right eye of each subject was randomized to receive either Lumify or balanced saline solution.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="43"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Palpebral Fissure Height</title>
        <description>Objective measurement of distance between inner margin of upper and lower eyelids from clinical photographs.</description>
        <time_frame>Baseline, 5, 15 and 30 minutes after application</time_frame>
        <population>All participants received both the Lumify and saline solution. The left and right eye of each subject was randomized to receive either Lumify or balanced saline solution. Measurements from 3 participants were not collected due to brow ptosis.</population>
        <group_list>
          <group group_id="O1">
            <title>Lumify Eye Drop</title>
            <description>Participants will be randomized to receive a single drop of Lumify to either the left or right eye.&#xD;
Brimonidine tartrate ophthalmic solution 0.025%: One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface)</description>
          </group>
          <group group_id="O2">
            <title>Saline Solution Eye Drop</title>
            <description>Participants will be randomized to receive a single drop of sterile balanced saline solution to either the left or right eye.&#xD;
Sterile balanced saline solution: One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)</description>
          </group>
        </group_list>
        <measure>
          <title>Palpebral Fissure Height</title>
          <description>Objective measurement of distance between inner margin of upper and lower eyelids from clinical photographs.</description>
          <population>All participants received both the Lumify and saline solution. The left and right eye of each subject was randomized to receive either Lumify or balanced saline solution. Measurements from 3 participants were not collected due to brow ptosis.</population>
          <units>milimeter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>eye</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eye</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.64" spread="1.71"/>
                    <measurement group_id="O2" value="9.66" spread="1.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 minutes after application</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.92" spread="1.33"/>
                    <measurement group_id="O2" value="9.96" spread="1.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes after application</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.85" spread="1.42"/>
                    <measurement group_id="O2" value="9.96" spread="1.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes after application</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.86" spread="1.32"/>
                    <measurement group_id="O2" value="9.84" spread="1.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intraocular Pressure</title>
        <description>Measurement of intraocular pressure using handheld Tono-Pen(tm) tonometer</description>
        <time_frame>Baseline, 5, 15 and 30 minutes after application</time_frame>
        <population>All participants received both the Lumify and saline solution. The left and right eye of each subject was randomized to receive either Lumify or balanced saline solution. Intraocular Pressure was only conducted at Baseline and 30 minutes post application.</population>
        <group_list>
          <group group_id="O1">
            <title>Lumify Eye Drop</title>
            <description>Participants will be randomized to receive a single drop of Lumify to either the left or right eye.&#xD;
Brimonidine tartrate ophthalmic solution 0.025%: One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface)</description>
          </group>
          <group group_id="O2">
            <title>Saline Solution Eye Drop</title>
            <description>Participants will be randomized to receive a single drop of sterile balanced saline solution to either the left or right eye.&#xD;
Sterile balanced saline solution: One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)</description>
          </group>
        </group_list>
        <measure>
          <title>Intraocular Pressure</title>
          <description>Measurement of intraocular pressure using handheld Tono-Pen(tm) tonometer</description>
          <population>All participants received both the Lumify and saline solution. The left and right eye of each subject was randomized to receive either Lumify or balanced saline solution. Intraocular Pressure was only conducted at Baseline and 30 minutes post application.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>eye</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eye</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.54" spread="3.63"/>
                    <measurement group_id="O2" value="16.70" spread="3.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes after applciation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.54" spread="3.30"/>
                    <measurement group_id="O2" value="15.58" spread="2.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Eye Redness</title>
        <description>Eye redness will be reported as the number of participants achieving a score of ocular redness from clinical photographs as 0 (none), 1 (mild), 2 (moderate) and 3 (severe).</description>
        <time_frame>Baseline, 5, 15 and 30 minutes after application</time_frame>
        <population>All participants received both the Lumify and saline solution. The left and right eye of each subject was randomized to receive either Lumify or balanced saline solution.</population>
        <group_list>
          <group group_id="O1">
            <title>Lumify Eye Drop</title>
            <description>Participants will be randomized to receive a single drop of Lumify to either the left or right eye.&#xD;
Brimonidine tartrate ophthalmic solution 0.025%: One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface)</description>
          </group>
          <group group_id="O2">
            <title>Saline Solution Eye Drop</title>
            <description>Participants will be randomized to receive a single drop of sterile balanced saline solution to either the left or right eye.&#xD;
Sterile balanced saline solution: One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)</description>
          </group>
        </group_list>
        <measure>
          <title>Eye Redness</title>
          <description>Eye redness will be reported as the number of participants achieving a score of ocular redness from clinical photographs as 0 (none), 1 (mild), 2 (moderate) and 3 (severe).</description>
          <population>All participants received both the Lumify and saline solution. The left and right eye of each subject was randomized to receive either Lumify or balanced saline solution.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline - None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline - Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline - Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline - Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 minutes after application - None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 minutes after application - Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 minutes after application - Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 minutes after application - Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes after application - None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes after application - Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes after application - Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes after application - Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes after application - None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes after application - Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes after application - Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes after application - Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Eye Discomfort</title>
        <description>Eye discomfort will be reported as the number of participants reporting subjective ocular discomfort score from 0 (none), 1 (mild), 2 (mild) and 3 (severe).</description>
        <time_frame>Baseline, 5, 15 and 30 minutes after application</time_frame>
        <population>All participants received both the Lumify and saline solution. The left and right eye of each subject was randomized to receive either Lumify or balanced saline solution.</population>
        <group_list>
          <group group_id="O1">
            <title>Lumify Eye Drop</title>
            <description>Participants will be randomized to receive a single drop of Lumify to either the left or right eye.&#xD;
Brimonidine tartrate ophthalmic solution 0.025%: One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface)</description>
          </group>
          <group group_id="O2">
            <title>Saline Solution Eye Drop</title>
            <description>Participants will be randomized to receive a single drop of sterile balanced saline solution to either the left or right eye.&#xD;
Sterile balanced saline solution: One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)</description>
          </group>
        </group_list>
        <measure>
          <title>Eye Discomfort</title>
          <description>Eye discomfort will be reported as the number of participants reporting subjective ocular discomfort score from 0 (none), 1 (mild), 2 (mild) and 3 (severe).</description>
          <population>All participants received both the Lumify and saline solution. The left and right eye of each subject was randomized to receive either Lumify or balanced saline solution.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline - None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline - Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline - Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline - Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 minutes after application - none</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 minutes after application - mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 minutes after application - moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 minutes after application - severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes after application - none</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes after application - mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes after application - moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes after application - severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes after application - none</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes after application - mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes after application - moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes after application - severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 30 minutes</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Lumify Eye Drop</title>
          <description>Participants will be randomized to receive a single drop of Lumify to either the left or right eye.&#xD;
Brimonidine tartrate ophthalmic solution 0.025%: One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface)</description>
        </group>
        <group group_id="E2">
          <title>Saline Solution Eye Drop</title>
          <description>Participants will be randomized to receive a single drop of sterile balanced saline solution to either the left or right eye.&#xD;
Sterile balanced saline solution: One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)</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="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Eye Itchiness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Eye Dryness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="43"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Dr. Wendy Lee</name_or_title>
      <organization>Bascom Palmer Eye Institute</organization>
      <phone>(305) 243-2020</phone>
      <email>wlee@med.miami.edu</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/NCT03782701
org study id: 20180895
nct id: NCT03782701
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of the research is to see if Lumify™ has an effect on eyelid position.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The left and right eye of each subject will be randomized to receive either Lumify or balanced saline placebo.
primary purpose: Treatment
masking: None (Open Label)
measure: Palpebral Fissure Height
time frame: Baseline, 5, 15 and 30 minutes after application
description: Objective measurement of distance between inner margin of upper and lower eyelids from clinical photographs.
measure: Intraocular Pressure
time frame: Baseline, 5, 15 and 30 minutes after application
description: Measurement of intraocular pressure using handheld Tono-Pen(tm) tonometer
measure: Eye Redness
time frame: Baseline, 5, 15 and 30 minutes after application
description: Eye redness will be reported as the number of participants achieving a score of ocular redness from clinical photographs as 0 (none), 1 (mild), 2 (moderate) and 3 (severe).
measure: Eye Discomfort
time frame: Baseline, 5, 15 and 30 minutes after application
description: Eye discomfort will be reported as the number of participants reporting subjective ocular discomfort score from 0 (none), 1 (mild), 2 (mild) and 3 (severe).
arm group label: Lumify Eye Drop
arm group type: Active Comparator
description: Participants will be randomized to receive a single drop of Lumify to either the left or right eye.
arm group label: Saline Solution Eye Drop
arm group type: Active Comparator
description: Participants will be randomized to receive a single drop of sterile balanced saline solution to either the left or right eye.
intervention type: Drug
intervention name: Brimonidine tartrate ophthalmic solution 0.025%
description: One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface)
arm group label: Lumify Eye Drop
other name: Lumify
intervention type: Other
intervention name: Sterile balanced saline solution
description: One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)
arm group label: Saline Solution Eye Drop
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Wendy W Lee, MD, MS
role: Principal Investigator
affiliation: Bascom Palmer Eye Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Wendy Lee
investigator title: Associate Professor of Ophthalmology and Dermatology
mesh term: Blepharoptosis
mesh term: Brimonidine Tartrate
mesh term: Pharmaceutical Solutions
mesh term: Ophthalmic Solutions
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 