<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/NCT02197806</url>
  </required_header>
  <id_info>
    <org_study_id>199201-007</org_study_id>
    <nct_id>NCT02197806</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of AGN-199201 and AGN-190584 in Patients With Presbyopia</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allergan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study to evaluate the safety and efficacy of AGN-199201 alone, AGN-190584 alone and&#xD;
      concurrent use of AGN-199201 and AGN-190584 in patients with presbyopia (inability to focus&#xD;
      for near vision).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye</measure>
    <time_frame>Baseline, Day 3</time_frame>
    <description>UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved. The percentages of patients with at least a 2 or more line improvement in UNVA in the non-dominant eye are presented.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Presbyopia</condition>
  <arm_group>
    <arm_group_label>AGN-199201</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AGN-190584</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AGN-199201 + AGN-190584 in One Eye</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AGN-199201 + AGN-190584 in Both Eyes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AGN-199201</intervention_name>
    <description>1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.</description>
    <arm_group_label>AGN-199201</arm_group_label>
    <arm_group_label>AGN-199201 + AGN-190584 in Both Eyes</arm_group_label>
    <arm_group_label>AGN-199201 + AGN-190584 in One Eye</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AGN-190584</intervention_name>
    <description>1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.</description>
    <arm_group_label>AGN-190584</arm_group_label>
    <arm_group_label>AGN-199201 + AGN-190584 in Both Eyes</arm_group_label>
    <arm_group_label>AGN-199201 + AGN-190584 in One Eye</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AGN-199201 Vehicle</intervention_name>
    <description>1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.</description>
    <arm_group_label>AGN-190584</arm_group_label>
    <arm_group_label>AGN-199201</arm_group_label>
    <arm_group_label>AGN-199201 + AGN-190584 in One Eye</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Presbyopia in each eye that impacts daily activities.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of any topical ophthalmic medications, including artificial tears&#xD;
&#xD;
          -  Contact lens use in either eye within 14 days or planned use during the study&#xD;
&#xD;
          -  History of eye surgery&#xD;
&#xD;
          -  Diagnosis of any type of glaucoma or ocular hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <results_first_submitted>October 30, 2015</results_first_submitted>
  <results_first_submitted_qc>October 30, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 3, 2015</results_first_posted>
  <last_update_submitted>October 30, 2015</last_update_submitted>
  <last_update_submitted_qc>October 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2015</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>Presbyopia</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>AGN-199201</title>
          <description>1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.</description>
        </group>
        <group group_id="P2">
          <title>AGN-190584</title>
          <description>1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.</description>
        </group>
        <group group_id="P3">
          <title>AGN-199201 + AGN-190584 in One Eye</title>
          <description>1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.</description>
        </group>
        <group group_id="P4">
          <title>AGN-199201 + AGN-190584 in Both Eyes</title>
          <description>1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AGN-199201</title>
          <description>1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.</description>
        </group>
        <group group_id="B2">
          <title>AGN-190584</title>
          <description>1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.</description>
        </group>
        <group group_id="B3">
          <title>AGN-199201 + AGN-190584 in One Eye</title>
          <description>1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.</description>
        </group>
        <group group_id="B4">
          <title>AGN-199201 + AGN-190584 in Both Eyes</title>
          <description>1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.</description>
        </group>
        <group group_id="B5">
          <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="15"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="16"/>
            <count group_id="B4" value="17"/>
            <count group_id="B5" value="65"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="49.9" spread="3.88"/>
                    <measurement group_id="B2" value="49.1" spread="3.47"/>
                    <measurement group_id="B3" value="48.7" spread="4.16"/>
                    <measurement group_id="B4" value="49.1" spread="3.97"/>
                    <measurement group_id="B5" value="49.2" spread="3.81"/>
                  </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="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye</title>
        <description>UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved. The percentages of patients with at least a 2 or more line improvement in UNVA in the non-dominant eye are presented.</description>
        <time_frame>Baseline, Day 3</time_frame>
        <population>Modified Intent to Treat: all randomized patients with a baseline assessment and at least 1 postbaseline assessment of UNVA</population>
        <group_list>
          <group group_id="O1">
            <title>AGN-199201</title>
            <description>1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.</description>
          </group>
          <group group_id="O2">
            <title>AGN-190584</title>
            <description>1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.</description>
          </group>
          <group group_id="O3">
            <title>AGN-199201 + AGN-190584 in One Eye</title>
            <description>1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.</description>
          </group>
          <group group_id="O4">
            <title>AGN-199201 + AGN-190584 in Both Eyes</title>
            <description>1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye</title>
          <description>UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved. The percentages of patients with at least a 2 or more line improvement in UNVA in the non-dominant eye are presented.</description>
          <population>Modified Intent to Treat: all randomized patients with a baseline assessment and at least 1 postbaseline assessment of UNVA</population>
          <units>Percentage of Patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.7"/>
                    <measurement group_id="O2" value="70.6"/>
                    <measurement group_id="O3" value="56.3"/>
                    <measurement group_id="O4" value="68.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>The Safety Population included all patients who received at least 1 dose of study treatment and was used to assess adverse events (AEs) and serious adverse events (SAEs).</desc>
      <group_list>
        <group group_id="E1">
          <title>AGN-199201</title>
          <description>1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.</description>
        </group>
        <group group_id="E2">
          <title>AGN-190584</title>
          <description>1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.</description>
        </group>
        <group group_id="E3">
          <title>AGN-199201 + AGN-190584 in One Eye</title>
          <description>1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.</description>
        </group>
        <group group_id="E4">
          <title>AGN-199201 + AGN-190584 in Both Eyes</title>
          <description>1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.</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="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA version 17.1</default_vocab>
        <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="5" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision Blurred</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Conjunctival Hyperaemia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Lacrimation Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Metamorphopsia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Ocular Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Eyelid Retraction</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Photophobia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Eye Irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Punctate Keratitis</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Product Taste Abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood Pressure Increased</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="17"/>
              </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>A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Therapeutic Area Head,</name_or_title>
      <organization>Allergan, Inc</organization>
      <phone>714-246-4500</phone>
      <email>clinicaltrials@allergan.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02197806
org study id: 199201-007
nct id: NCT02197806
lead sponsor: 
has dmc: No
A study to evaluate the safety and efficacy of AGN-199201 alone, AGN-190584 alone and
      concurrent use of AGN-199201 and AGN-190584 in patients with presbyopia (inability to focus
      for near vision).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye
time frame: Baseline, Day 3
description: UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved. The percentages of patients with at least a 2 or more line improvement in UNVA in the non-dominant eye are presented.
arm group label: AGN-199201
arm group type: Experimental
description: 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
arm group label: AGN-190584
arm group type: Experimental
description: 1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
arm group label: AGN-199201 + AGN-190584 in One Eye
arm group type: Experimental
description: 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
arm group label: AGN-199201 + AGN-190584 in Both Eyes
arm group type: Experimental
description: 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
intervention type: Drug
intervention name: AGN-199201
description: 1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.
arm group label: AGN-199201
arm group label: AGN-199201 + AGN-190584 in Both Eyes
arm group label: AGN-199201 + AGN-190584 in One Eye
intervention type: Drug
intervention name: AGN-190584
description: 1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.
arm group label: AGN-190584
arm group label: AGN-199201 + AGN-190584 in Both Eyes
arm group label: AGN-199201 + AGN-190584 in One Eye
intervention type: Drug
intervention name: AGN-199201 Vehicle
description: 1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.
arm group label: AGN-190584
arm group label: AGN-199201
arm group label: AGN-199201 + AGN-190584 in One Eye
criteria: 
gender: All
minimum age: 40 Years
maximum age: 55 Years
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Allergan
facility: 
country: United States
responsible party type: Sponsor
mesh term: Presbyopia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 