<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/NCT01711177</url>
  </required_header>
  <id_info>
    <org_study_id>OPM3117-Dubois/Pham</org_study_id>
    <nct_id>NCT01711177</nct_id>
  </id_info>
  <brief_title>Effect of Travoprost 0.004% on Retinal Oximetry in Primary Open Angle Glaucoma</brief_title>
  <official_title>Effect of Travoprost 0.004% on Retinal Oximetry in Primary Open Angle Glaucoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université de Montréal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Université de Montréal</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Glaucoma is the second leading cause of blindness among seniors in Canada. It is often&#xD;
      associated with an elevated intraocular pressure (IOP), but its exact mechanism is still&#xD;
      largely unknown. Some studies have shown a link between glaucoma and changes in the amount of&#xD;
      oxygen in the veins of the eye. The study aims to compare the amount of oxygen in ocular&#xD;
      veins among three different groups using a spectrophotometer. This instrument is linked to a&#xD;
      camera and can measure the quantity of oxygen in the veins using different characteristics of&#xD;
      the blood inside.&#xD;
&#xD;
      The groups of the study are: patients without glaucoma, patients suspected of glaucoma and&#xD;
      patients newly diagnosed with glaucoma. The drug the investigators are using, Travoprost&#xD;
      0.004%, will only be administered to the groups suspected or diagnosed with glaucoma.&#xD;
      Travoprost 0.004% is already approved for use in Quebec and is part of standard care. Ten&#xD;
      patients will be recruited into each group for a total of 30 patients in this study. All&#xD;
      patients for the suspected or diagnosed groups will be recruited from the Jewish General&#xD;
      Hospital. Subsequently all testing will be done at the École d'optométrie, Université de&#xD;
      Montréal&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Oxygenation</measure>
    <time_frame>1 hour</time_frame>
    <description>For each subject, all the measurements will be done during an 1 hour appointment.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Primary Open Angle Glaucoma</condition>
  <arm_group>
    <arm_group_label>Normal control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Normal patient placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glaucoma suspect</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Newly diagnosed glaucoma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treated with Travoprost (0.04%)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Glaucoma suspect</arm_group_label>
    <arm_group_label>Normal control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>travoprost</intervention_name>
    <description>Travatan Z is administered to newly diagnosed glaucoma patient</description>
    <arm_group_label>Newly diagnosed glaucoma</arm_group_label>
    <other_name>travatan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  good systemic health&#xD;
&#xD;
          -  irido-corneal angle open&#xD;
&#xD;
          -  intraocular pressure more than 18 mmHg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having cardiovascular problem&#xD;
&#xD;
          -  Hypertension or diabetes&#xD;
&#xD;
          -  under systemic medication for high blood pressure&#xD;
&#xD;
          -  had an ocular surgery in the past&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Montreal</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3t1P1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <results_first_submitted>June 16, 2016</results_first_submitted>
  <results_first_submitted_qc>June 16, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 28, 2016</results_first_posted>
  <last_update_submitted>June 16, 2016</last_update_submitted>
  <last_update_submitted_qc>June 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Université de Montréal</investigator_affiliation>
    <investigator_full_name>Pierre Forcier</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>primary open angle glaucoma</keyword>
  <keyword>retinal oximetry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Travoprost</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Normal Control</title>
          <description>Normal patient placebo&#xD;
placebo: Placebo</description>
        </group>
        <group group_id="P2">
          <title>Glaucoma Suspect</title>
          <description>Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)&#xD;
placebo: Placebo</description>
        </group>
        <group group_id="P3">
          <title>Newly Diagnosed Glaucoma</title>
          <description>Treated with Travoprost (0.04%)&#xD;
travoprost: Travatan Z is administered to newly diagnosed glaucoma patient</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Normal Control</title>
          <description>Normal patient placebo&#xD;
placebo: Placebo</description>
        </group>
        <group group_id="B2">
          <title>Glaucoma Suspect</title>
          <description>Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)&#xD;
placebo: Placebo</description>
        </group>
        <group group_id="B3">
          <title>Newly Diagnosed Glaucoma</title>
          <description>Treated with Travoprost (0.04%)&#xD;
travoprost: Travatan Z is administered to newly diagnosed glaucoma patient</description>
        </group>
        <group group_id="B4">
          <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="10"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="3"/>
            <count group_id="B4" value="16"/>
          </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </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="50" spread="5"/>
                    <measurement group_id="B2" value="53" spread="8"/>
                    <measurement group_id="B3" value="60" spread="9"/>
                    <measurement group_id="B4" value="55" spread="10"/>
                  </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="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Blood Oxygenation</title>
        <description>For each subject, all the measurements will be done during an 1 hour appointment.</description>
        <time_frame>1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Normal Control</title>
            <description>Normal patient placebo&#xD;
placebo: Placebo</description>
          </group>
          <group group_id="O2">
            <title>Glaucoma Suspect</title>
            <description>Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)&#xD;
placebo: Placebo</description>
          </group>
          <group group_id="O3">
            <title>Newly Diagnosed Glaucoma</title>
            <description>Treated with Travoprost (0.04%)&#xD;
travoprost: Travatan Z is administered to newly diagnosed glaucoma patient</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Oxygenation</title>
          <description>For each subject, all the measurements will be done during an 1 hour appointment.</description>
          <units>percentage of oxygenation</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" lower_limit="55" upper_limit="63"/>
                    <measurement group_id="O2" value="60" lower_limit="55" upper_limit="63"/>
                    <measurement group_id="O3" value="60" lower_limit="55" upper_limit="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 month</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Normal Control</title>
          <description>Normal patient placebo&#xD;
placebo: Placebo</description>
        </group>
        <group group_id="E2">
          <title>Glaucoma Suspect</title>
          <description>Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)&#xD;
placebo: Placebo</description>
        </group>
        <group group_id="E3">
          <title>Newly Diagnosed Glaucoma</title>
          <description>Treated with Travoprost (0.04%)&#xD;
travoprost: Travatan Z is administered to newly diagnosed glaucoma patient</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </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>Pierre Forcier</name_or_title>
      <organization>Université de Montreal</organization>
      <phone>514-343-7468</phone>
      <email>pierre.forcier@umontreal.ca</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/NCT01711177
org study id: OPM3117-Dubois/Pham
nct id: NCT01711177
lead sponsor: 
has dmc: Yes
Glaucoma is the second leading cause of blindness among seniors in Canada. It is often
      associated with an elevated intraocular pressure (IOP), but its exact mechanism is still
      largely unknown. Some studies have shown a link between glaucoma and changes in the amount of
      oxygen in the veins of the eye. The study aims to compare the amount of oxygen in ocular
      veins among three different groups using a spectrophotometer. This instrument is linked to a
      camera and can measure the quantity of oxygen in the veins using different characteristics of
      the blood inside.

      The groups of the study are: patients without glaucoma, patients suspected of glaucoma and
      patients newly diagnosed with glaucoma. The drug the investigators are using, Travoprost
      0.004%, will only be administered to the groups suspected or diagnosed with glaucoma.
      Travoprost 0.004% is already approved for use in Quebec and is part of standard care. Ten
      patients will be recruited into each group for a total of 30 patients in this study. All
      patients for the suspected or diagnosed groups will be recruited from the Jewish General
      Hospital. Subsequently all testing will be done at the École d'optométrie, Université de
      Montréal
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Blood Oxygenation
time frame: 1 hour
description: For each subject, all the measurements will be done during an 1 hour appointment.
arm group label: Normal control
arm group type: Sham Comparator
description: Normal patient placebo
arm group label: Glaucoma suspect
arm group type: Sham Comparator
description: Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)
arm group label: Newly diagnosed glaucoma
arm group type: Experimental
description: Treated with Travoprost (0.04%)
intervention type: Drug
intervention name: placebo
description: Placebo
arm group label: Glaucoma suspect
arm group label: Normal control
intervention type: Drug
intervention name: travoprost
description: Travatan Z is administered to newly diagnosed glaucoma patient
arm group label: Newly diagnosed glaucoma
other name: travatan
criteria: 
gender: All
minimum age: 45 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Université de Montréal
investigator full name: Pierre Forcier
investigator title: Associate professor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Travoprost
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 