<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/NCT03760185</url>
  </required_header>
  <id_info>
    <org_study_id>18-1713</org_study_id>
    <nct_id>NCT03760185</nct_id>
  </id_info>
  <brief_title>Pupil Dilation for Treatment of IFIS</brief_title>
  <official_title>Enhanced Pupil Dilation in Patients Taking Alpha-Blockers for Potential Treatment of Intraoperative Floppy Iris Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Denver Health and Hospital Authority</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Denver Health and Hospital Authority</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A novel intervention for targeting the treatment of Intraoperative Floppy Iris Syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study explores the effects that medication can have on increasing pupil dilation. Pupil&#xD;
      dilation size is important for operative eye procedures. Decreased pupil size is related to&#xD;
      increased complication risks in eye surgery. By exploring novel pupil dilation techniques,&#xD;
      there is a potential to counteract the effects of poor pupil dilation that is caused by&#xD;
      medications such as alpha-blockers. Intraoperative floppy iris syndrome is a syndrome&#xD;
      characterized by a floppy iris (IFIS) and poor pupil dilation during surgery that is caused&#xD;
      by BPH medications. This study evaluates treatment methods targeting IFIS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 4, 2019</start_date>
  <completion_date type="Actual">September 25, 2020</completion_date>
  <primary_completion_date type="Actual">September 25, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This is a single arm study in which all enrolled subjects will receive eye drops to only one eye. The alternative eye will serve as the control for efficacy.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pupil Dilation Sized of the Treated Eye Compared to the Non-treated Eye</measure>
    <time_frame>45 minutes post dilation after 7 days of treatment</time_frame>
    <description>The primary outcome measure is pupil diameter size post dilation (using standard dilating medications of phenylephrine 10%, tropicamide 1%, and cyclopentolate 1%) of the brimonidine tartrate pre-treated eye compared to the non-treated eye</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Pupil Diameter of Each Eye After Dilation at the Start of the Study Compared to Pupil Post Dilating Drops at the End of the Study</measure>
    <time_frame>45 minutes post dilation after 7 days of treatment</time_frame>
    <description>Change in pupil diameter of each eye after dilation at the start of the study compared to pupil post dilating drops at the end of the study</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Intraoperative Floppy Iris Syndrome</condition>
  <arm_group>
    <arm_group_label>Brimonidine Tartrate 0.2%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One eye was treated with Brimonidine Tartrate 0.2% after a 20-day washout period. Patients will treat right eye 3 times per day for 7 days of treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control - untreated</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The left eye will serve as the control for the study and will not receive the Brimonidine Tartrate 0.2% treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Brimonidine Tartrate</intervention_name>
    <description>All subjects will apply brimonidine tartrate to one eye (right eye) only for the duration of study participation.</description>
    <arm_group_label>Brimonidine Tartrate 0.2%</arm_group_label>
    <other_name>&quot;Eye Drops&quot;</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Adults (18 years old or greater) 3. History of having taken, or currently taking any&#xD;
        systemic alpha blocker 2. Ability to consent themselves 3. Ability to apply eye drops&#xD;
        themselves TID for 7 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with untreated hypertension or baseline BP &gt;160&#xD;
&#xD;
          2. Subjects with Thyrotoxicosis&#xD;
&#xD;
          3. Pregnant women or women trying to conceive&#xD;
&#xD;
          4. Prisoners&#xD;
&#xD;
          5. Inability consent&#xD;
&#xD;
          6. Subjects with anatomical narrow angles or who have never had a dilated eye exam&#xD;
&#xD;
          7. Subjects currently prescribed brimonidine tartrate for glaucoma&#xD;
&#xD;
          8. Subjects who take topical or systemic alpha agonists&#xD;
&#xD;
          9. Patients who take monoamine oxidase (MAO) inhibitors&#xD;
&#xD;
         10. Patients with known severe cardiovascular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cristos Ifantides, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Denver Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Denver Health</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <results_first_submitted>December 10, 2021</results_first_submitted>
  <results_first_submitted_qc>March 28, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">April 20, 2022</results_first_posted>
  <last_update_submitted>March 28, 2022</last_update_submitted>
  <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2022</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>Mydriasis</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brimonidine Tartrate</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>February 22, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/85/NCT03760185/Prot_SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/85/NCT03760185/ICF_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients will be screened at their annual eye examination at the hospital eye clinic.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Brimonidine Tartrate 0.2%</title>
          <description>All enrolled subjects will receive the interventional drug, Brimonidine tartrate 0.2%, to be applied to ONE eye only.</description>
        </group>
        <group group_id="P2">
          <title>Control- Untreated</title>
          <description>All subjects enrolled will have one eye serve as a control and will not receive the Brimonidine Tartrate 0.2% treatment</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Patients</title>
          <description>All patients in this arm will receive eye drops to be applied to one eye only. The alternative eye will not receive any eye drops and as such will serve as the control.&#xD;
Brimonidine Tartrate: All subjects will apply brimonidine tartrate to one eye only for the duration of study participation.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="13"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.9" spread="10.1"/>
                  </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="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </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>
          <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>
          <title>Pre-Study Treatment Pupil Diameter Dilated</title>
          <units>milimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.50" spread="1.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pupil Dilation Sized of the Treated Eye Compared to the Non-treated Eye</title>
        <description>The primary outcome measure is pupil diameter size post dilation (using standard dilating medications of phenylephrine 10%, tropicamide 1%, and cyclopentolate 1%) of the brimonidine tartrate pre-treated eye compared to the non-treated eye</description>
        <time_frame>45 minutes post dilation after 7 days of treatment</time_frame>
        <population>One participant did not show for their follow-up visit after treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Brimonidine Tartrate 0.2%</title>
            <description>The eye that was treated with Brimonidine Tartrate 0.2%.</description>
          </group>
          <group group_id="O2">
            <title>Control - Untreated</title>
            <description>Eye of participant that was not treated with Brimonidine Tartrate 0.2%</description>
          </group>
        </group_list>
        <measure>
          <title>Pupil Dilation Sized of the Treated Eye Compared to the Non-treated Eye</title>
          <description>The primary outcome measure is pupil diameter size post dilation (using standard dilating medications of phenylephrine 10%, tropicamide 1%, and cyclopentolate 1%) of the brimonidine tartrate pre-treated eye compared to the non-treated eye</description>
          <population>One participant did not show for their follow-up visit after treatment.</population>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.76" spread="2.57"/>
                    <measurement group_id="O2" value="7.17" spread="1.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pupil Diameter of Each Eye After Dilation at the Start of the Study Compared to Pupil Post Dilating Drops at the End of the Study</title>
        <description>Change in pupil diameter of each eye after dilation at the start of the study compared to pupil post dilating drops at the end of the study</description>
        <time_frame>45 minutes post dilation after 7 days of treatment</time_frame>
        <population>1 patient did not return for their post-treatment follow-up visit</population>
        <group_list>
          <group group_id="O1">
            <title>Brimonidine Tartrate 0.2%</title>
            <description>Eye that was treated with Brimonidine Tartrate 0.2%</description>
          </group>
          <group group_id="O2">
            <title>Control - Untreated</title>
            <description>Eye that was not treated with Brimonidine Tartrate 0.2%</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pupil Diameter of Each Eye After Dilation at the Start of the Study Compared to Pupil Post Dilating Drops at the End of the Study</title>
          <description>Change in pupil diameter of each eye after dilation at the start of the study compared to pupil post dilating drops at the end of the study</description>
          <population>1 patient did not return for their post-treatment follow-up visit</population>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.39" spread="2.20"/>
                    <measurement group_id="O2" value="0.91" spread="1.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>up to 30 days from enrollment.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Brimonidine Tartrate 0.2%</title>
          <description>The eye that was treated with Brimonidine Tartrate 0.2%.</description>
        </group>
        <group group_id="E2">
          <title>Control- Untreated</title>
          <description>The eye that was not treated with Brimonidine Tartrate 0.2%.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Surgery- Cryoablation of prostate</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardio - MI</sub_title>
                <description>Patient disclosed to study PI that he had an MI and was treated at an outside hospital with a stent surgery.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Ophthalmology - Cataracts</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Kidney &amp; Urinary tract</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </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>Dr Cristos Ifantides</name_or_title>
      <organization>Denver Health and Hospital Authority</organization>
      <phone>303-436-4949</phone>
      <email>Cristos.Ifantides@dhha.org</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/NCT03760185
org study id: 18-1713
nct id: NCT03760185
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
A novel intervention for targeting the treatment of Intraoperative Floppy Iris Syndrome.
This study explores the effects that medication can have on increasing pupil dilation. Pupil
      dilation size is important for operative eye procedures. Decreased pupil size is related to
      increased complication risks in eye surgery. By exploring novel pupil dilation techniques,
      there is a potential to counteract the effects of poor pupil dilation that is caused by
      medications such as alpha-blockers. Intraoperative floppy iris syndrome is a syndrome
      characterized by a floppy iris (IFIS) and poor pupil dilation during surgery that is caused
      by BPH medications. This study evaluates treatment methods targeting IFIS.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: This is a single arm study in which all enrolled subjects will receive eye drops to only one eye. The alternative eye will serve as the control for efficacy.
primary purpose: Treatment
masking: None (Open Label)
measure: Pupil Dilation Sized of the Treated Eye Compared to the Non-treated Eye
time frame: 45 minutes post dilation after 7 days of treatment
description: The primary outcome measure is pupil diameter size post dilation (using standard dilating medications of phenylephrine 10%, tropicamide 1%, and cyclopentolate 1%) of the brimonidine tartrate pre-treated eye compared to the non-treated eye
measure: Change in Pupil Diameter of Each Eye After Dilation at the Start of the Study Compared to Pupil Post Dilating Drops at the End of the Study
time frame: 45 minutes post dilation after 7 days of treatment
description: Change in pupil diameter of each eye after dilation at the start of the study compared to pupil post dilating drops at the end of the study
arm group label: Brimonidine Tartrate 0.2%
arm group type: Experimental
description: One eye was treated with Brimonidine Tartrate 0.2% after a 20-day washout period. Patients will treat right eye 3 times per day for 7 days of treatment.
arm group label: Control - untreated
arm group type: No Intervention
description: The left eye will serve as the control for the study and will not receive the Brimonidine Tartrate 0.2% treatment
intervention type: Drug
intervention name: Brimonidine Tartrate
description: All subjects will apply brimonidine tartrate to one eye (right eye) only for the duration of study participation.
arm group label: Brimonidine Tartrate 0.2%
other name: "Eye Drops"
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Cristos Ifantides, MD
role: Principal Investigator
affiliation: Denver Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Mydriasis
mesh term: Syndrome
mesh term: Brimonidine Tartrate
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 