<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/NCT01698814</url>
  </required_header>
  <id_info>
    <org_study_id>C-12-028</org_study_id>
    <nct_id>NCT01698814</nct_id>
  </id_info>
  <brief_title>A Six-Week Safety Study of an Investigational Ophthalmic Solution</brief_title>
  <official_title>A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AL-4943A Ophthalmic Solution Administered Once Daily</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alcon Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alcon Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to evaluate the ocular safety of an investigational ophthalmic&#xD;
      solution in subjects 2 years of age and older with asymptomatic eyes when administered once&#xD;
      daily in both eyes for up to 6 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>Phase 3</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>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>An average of 6 weeks</time_frame>
    <description>An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">518</enrollment>
  <condition>Allergic Conjunctivitis</condition>
  <arm_group>
    <arm_group_label>AL-4943A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AL-4943A Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AL-4943A Ophthalmic Solution</intervention_name>
    <arm_group_label>AL-4943A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AL-4943A Ophthalmic Solution Vehicle</intervention_name>
    <description>Inactive ingredients used as placebo</description>
    <arm_group_label>AL-4943A Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able and willing to comply with study protocol and follow protocol instructions.&#xD;
&#xD;
          -  Adequate birth control methods for the duration of the study.&#xD;
&#xD;
          -  Best-corrected visual acuity (BCVA) of 55 or greater in each eye.&#xD;
&#xD;
          -  Willing to avoid contact lens wear during each of the study visits; contact lens wear&#xD;
             also should be stable and consistent for 1 month prior to Visit 1 and expected to&#xD;
             remain the same for the study duration.&#xD;
&#xD;
          -  Willing and able to sign an Informed Consent form.&#xD;
&#xD;
          -  Other protocol-specified inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women of childbearing potential that are pregnant, breastfeeding, or not in agreement&#xD;
             to use adequate birth control methods to prevent pregnancy throughout the study.&#xD;
&#xD;
          -  Evidence of contact lens care solution related ocular surface damage or giant&#xD;
             papillary conjunctivitis (GPC).&#xD;
&#xD;
          -  Any ocular infection (bacterial, viral or fungal) or history of ocular Herpes (simplex&#xD;
             or zoster) or adenoviral infection in either eye or have had any ocular infection&#xD;
             within 30 days prior to Visit 1.&#xD;
&#xD;
          -  Using systemic medication(s) on a chronic dosing regimen for less than 30 days or&#xD;
             changed dosage of this medication within 30 days prior to Visit 1.&#xD;
&#xD;
          -  Current or past history of glaucoma or ocular hypertension.&#xD;
&#xD;
          -  History of retinal detachment, diabetic retinopathy, or progressive retinal disease.&#xD;
&#xD;
          -  Presence of ocular conditions that may affect the study outcomes.&#xD;
&#xD;
          -  Corneal conditions affecting the corneal structure.&#xD;
&#xD;
          -  History or evidence of any ocular surgical procedure within 1 year prior to Visit 1.&#xD;
&#xD;
          -  Current or recent medical conditions that, in the opinion of the Investigator, would&#xD;
             preclude safe participation in the study.&#xD;
&#xD;
          -  Prior, current, or anticipated use of ophthalmic agents other than investigational&#xD;
             product during study participation.&#xD;
&#xD;
          -  Participation in any investigational study within 30 days prior to Visit 1 or&#xD;
             concomitantly with this study.&#xD;
&#xD;
          -  Known contraindications or hypersensitivities to any of the study medications or their&#xD;
             components.&#xD;
&#xD;
          -  Other protocol-specified exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Terri Pasquine</last_name>
    <role>Study Director</role>
    <affiliation>Alcon Research</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <results_first_submitted>January 21, 2014</results_first_submitted>
  <results_first_submitted_qc>January 21, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 28, 2014</results_first_posted>
  <last_update_submitted>February 27, 2014</last_update_submitted>
  <last_update_submitted_qc>February 27, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 27, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ocular safety</keyword>
  <keyword>allergic conjunctivitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Conjunctivitis</mesh_term>
    <mesh_term>Conjunctivitis, Allergic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Olopatadine Hydrochloride</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
    <mesh_term>Ophthalmic Solutions</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited from 15 study centers located in the United States.</recruitment_details>
      <pre_assignment_details>Of the 518 enrolled subjects, 18 subjects were exited from the study as screen failures. This reporting group includes all randomized subjects.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>AL-4943A</title>
          <description>AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks</description>
        </group>
        <group group_id="P2">
          <title>AL-4943A Vehicle</title>
          <description>AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="331"/>
                <participants group_id="P2" count="169"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="329"/>
                <participants group_id="P2" count="166"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </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="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized in error</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>This reporting group includes all randomized subjects who received study medication.</population>
      <group_list>
        <group group_id="B1">
          <title>AL-4943A</title>
          <description>AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks</description>
        </group>
        <group group_id="B2">
          <title>AL-4943A Vehicle</title>
          <description>AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="330"/>
            <count group_id="B2" value="169"/>
            <count group_id="B3" value="499"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>2-11 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-17 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18-64 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="272"/>
                    <measurement group_id="B2" value="141"/>
                    <measurement group_id="B3" value="413"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="11"/>
                  </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="214"/>
                    <measurement group_id="B2" value="111"/>
                    <measurement group_id="B3" value="325"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Adverse Events</title>
        <description>An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.</description>
        <time_frame>An average of 6 weeks</time_frame>
        <population>This reporting group includes all randomized subjects who received study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>AL-4943A</title>
            <description>AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks</description>
          </group>
          <group group_id="O2">
            <title>AL-4943A Vehicle</title>
            <description>AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events</title>
          <description>An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.</description>
          <population>This reporting group includes all randomized subjects who received study medication.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="330"/>
                <count group_id="O2" value="169"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Deaths</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>Non-Fatal Serious Adverse Events</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>Discontinuations Due to an Adverse Event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events (AE) were collected for the duration of the study (3 months). An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment.</time_frame>
      <desc>This reporting group includes all randomized subjects who received study medication. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.</desc>
      <group_list>
        <group group_id="E1">
          <title>AL-4943A</title>
          <description>AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks</description>
        </group>
        <group group_id="E2">
          <title>AL-4943A Vehicle</title>
          <description>AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks</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="330"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="330"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </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>Sponsor reserves the right of prior review of any publication or presentation of information related to the study.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Terri Pasquine, Sr. Clinical Project Lead</name_or_title>
      <organization>Alcon Research, Ltd.</organization>
      <phone>1-888-451-3937</phone>
      <email>alcon.medinfo@alcon.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/NCT01698814
org study id: C-12-028
nct id: NCT01698814
lead sponsor: 
has dmc: No
The purpose of this study was to evaluate the ocular safety of an investigational ophthalmic
      solution in subjects 2 years of age and older with asymptomatic eyes when administered once
      daily in both eyes for up to 6 weeks.
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Investigator)
measure: Adverse Events
time frame: An average of 6 weeks
description: An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.
arm group label: AL-4943A
arm group type: Experimental
description: AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
arm group label: AL-4943A Vehicle
arm group type: Placebo Comparator
description: AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
intervention type: Drug
intervention name: AL-4943A Ophthalmic Solution
arm group label: AL-4943A
intervention type: Drug
intervention name: AL-4943A Ophthalmic Solution Vehicle
description: Inactive ingredients used as placebo
arm group label: AL-4943A Vehicle
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Terri Pasquine
role: Study Director
affiliation: Alcon Research
country: United States
responsible party type: Sponsor
mesh term: Conjunctivitis
mesh term: Conjunctivitis, Allergic
mesh term: Olopatadine Hydrochloride
mesh term: Pharmaceutical Solutions
mesh term: Ophthalmic Solutions
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 