<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/NCT01697969</url>
  </required_header>
  <id_info>
    <org_study_id>M-12-047</org_study_id>
    <nct_id>NCT01697969</nct_id>
  </id_info>
  <brief_title>Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients</brief_title>
  <official_title>Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients Pre and Post Treatment With Olopatadine HCL Ophthalmic Solution, 0.2%</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 is to descriptively evaluate the corneal structures of allergic&#xD;
      conjunctivitis patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Heidelberg Retina Tomograph (HRT) will be used to descriptively evaluate the corneal&#xD;
      structures and assess the immune cell status of allergic conjunctivitis patients pre- and&#xD;
      post-treatment with olopatadine 0.2% in relation to a normative database.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient-Assessed Ocular Itching</measure>
    <time_frame>Baseline (Day 1), Day 14</time_frame>
    <description>The patient rated the severity of ocular itching using a predetermined 0-4 scale, where 0=none and 4=severe itching with irresistible urge to rub. Each eye was rated separately. A 2-week washout period from prior allergy medication (if applicable) preceded the baseline assessment.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Allergic Conjunctivitis</condition>
  <arm_group>
    <arm_group_label>Pataday</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Olopatadine hydrochloride ophthalmic solution, 0.2%</intervention_name>
    <arm_group_label>Pataday</arm_group_label>
    <other_name>PATADAY®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Read, sign, and date an Ethics Committee reviewed and approved informed consent form.&#xD;
&#xD;
          -  Females of childbearing potential who:&#xD;
&#xD;
               -  Are not breast-feeding;&#xD;
&#xD;
               -  Do not intend to become pregnant for the duration of the study;&#xD;
&#xD;
               -  Are using adequate birth control methods and agree to continue for the duration&#xD;
                  of the study.&#xD;
&#xD;
          -  Able to read, understand and answer questions by investigator.&#xD;
&#xD;
          -  Willing and able to attend all required study visits and follow directions as&#xD;
             stipulated by the protocol and investigator.&#xD;
&#xD;
          -  History of allergic conjunctivitis (within the past 12 months) and active signs and&#xD;
             symptoms of ocular allergies for which treatment is necessary, in the opinion of the&#xD;
             investigator.&#xD;
&#xD;
          -  Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with or&#xD;
             without glasses correction.&#xD;
&#xD;
          -  Ocular health within normal limits as determined by the investigator.&#xD;
&#xD;
          -  No contact lens wear 14 days prior to enrollment and willing to not wear contact&#xD;
             lenses for the duration of the study.&#xD;
&#xD;
          -  Willing to follow a 14-day washout period due to contraindicated medication use, if&#xD;
             deemed necessary by investigator.&#xD;
&#xD;
          -  Other protocol-defined inclusion criteria may apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications or hypersensitivity to the use of the test article or its&#xD;
             components.&#xD;
&#xD;
          -  Inability or unwillingness to follow all study instructions and complete study visits&#xD;
             as required.&#xD;
&#xD;
          -  Only one sighted eye or visual acuity not correctable to 20/30 (Snellen) in both eyes&#xD;
             at the Screening Visit.&#xD;
&#xD;
          -  Ocular trauma within 6 months prior to Visit 1 in either eye.&#xD;
&#xD;
          -  Any ocular surgical intervention within six months prior to Visit 1 or anticipation of&#xD;
             ocular surgery during the study.&#xD;
&#xD;
          -  Presumed or actual ocular infection within 30 days prior to Visit 1.&#xD;
&#xD;
          -  Any severe or serious ocular condition or significant illness.&#xD;
&#xD;
          -  Any abnormal slit-lamp findings at the time of the Screening Visit.&#xD;
&#xD;
          -  Contact lens wear within 14 days prior to the study start and unwillingness to undergo&#xD;
             a wash-out period of 14 days; unwilling to not wear contact lenses for the duration of&#xD;
             the study.&#xD;
&#xD;
          -  Use of over-the-counter (OTC) ocular medications within the past 14 days unless&#xD;
             willing to follow wash out period.&#xD;
&#xD;
          -  Use of topical or systemic ocular medications requiring longer than a two-week washout&#xD;
             period.&#xD;
&#xD;
          -  Participation in any other investigational study in the 30-day period before entry&#xD;
             into this study (i.e., Visit 1) or concomitantly with this study.&#xD;
&#xD;
          -  Women who are pregnant, nursing, or of childbearing potential not utilizing adequate&#xD;
             birth control measures.&#xD;
&#xD;
          -  Other protocol-defined exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christine Sindt, OD, FAAO</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pam Kaur, MS PhD</last_name>
    <role>Study Director</role>
    <affiliation>Alcon Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242-1091</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 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 2, 2012</study_first_posted>
  <results_first_submitted>July 30, 2014</results_first_submitted>
  <results_first_submitted_qc>July 30, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 18, 2014</results_first_posted>
  <last_update_submitted>July 30, 2014</last_update_submitted>
  <last_update_submitted_qc>July 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>allergic conjunctivitis</keyword>
  <keyword>Pataday</keyword>
  <keyword>Olopatadine</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>Ophthalmic Solutions</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from 1 study center located in the United States.</recruitment_details>
      <pre_assignment_details>Of the 17 participants enrolled, 4 were exited from the study as screen failures prior to exposure to the test product. This reporting group includes all participants exposed to the test product (13).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Overall Study</title>
          <description>Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days</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_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Did not meet inc/exc criteria</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>This analysis population includes all participants exposed to the test product.</population>
      <group_list>
        <group group_id="B1">
          <title>Overall Study</title>
          <description>Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days</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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.0" spread="12.0"/>
                  </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="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Patient-Assessed Ocular Itching</title>
        <description>The patient rated the severity of ocular itching using a predetermined 0-4 scale, where 0=none and 4=severe itching with irresistible urge to rub. Each eye was rated separately. A 2-week washout period from prior allergy medication (if applicable) preceded the baseline assessment.</description>
        <time_frame>Baseline (Day 1), Day 14</time_frame>
        <population>The analysis population includes all participants exposed to the test product. Here, &quot;n&quot; is the number of participants with non-missing values at the specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Left Eye</title>
            <description>Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily for 14 days</description>
          </group>
          <group group_id="O2">
            <title>Right Eye</title>
            <description>Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily for 14 days</description>
          </group>
        </group_list>
        <measure>
          <title>Patient-Assessed Ocular Itching</title>
          <description>The patient rated the severity of ocular itching using a predetermined 0-4 scale, where 0=none and 4=severe itching with irresistible urge to rub. Each eye was rated separately. A 2-week washout period from prior allergy medication (if applicable) preceded the baseline assessment.</description>
          <population>The analysis population includes all participants exposed to the test product. Here, &quot;n&quot; is the number of participants with non-missing values at the specific time point.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Day 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="0.85"/>
                    <measurement group_id="O2" value="2.2" spread="0.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 (n=11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="0.52"/>
                    <measurement group_id="O2" value="0.5" spread="0.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected for the duration of the study (October 11, 2012 to July 25, 2013). This analysis group includes all participants exposed to the test product.</time_frame>
      <desc>At each visit, after the subject had the opportunity to spontaneously mention any problems, the investigator inquired about AEs by asking the standard questions, &quot;Have you had any health problems since your last study visit? Have there been any changes in the medicines you take since your last study visit?&quot;</desc>
      <group_list>
        <group group_id="E1">
          <title>Overall Study</title>
          <description>Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days</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="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 15.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Arthropod infestation</sub_title>
                <counts group_id="E1" 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>Sponsor reserves the right of prior review of any publication or presentation of information related to the study.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The lack of concurrent control made it difficult to discriminate changes caused by PATADAY® from that caused by other factors, such as observer or patient expectation. Open-labeled design increased the bias from the observer or patient expectation.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Danyel Crout Carr, MS, CCRA</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/NCT01697969
org study id: M-12-047
nct id: NCT01697969
lead sponsor: 
has dmc: No
The purpose of this study is to descriptively evaluate the corneal structures of allergic
      conjunctivitis patients.
Heidelberg Retina Tomograph (HRT) will be used to descriptively evaluate the corneal
      structures and assess the immune cell status of allergic conjunctivitis patients pre- and
      post-treatment with olopatadine 0.2% in relation to a normative database.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Patient-Assessed Ocular Itching
time frame: Baseline (Day 1), Day 14
description: The patient rated the severity of ocular itching using a predetermined 0-4 scale, where 0=none and 4=severe itching with irresistible urge to rub. Each eye was rated separately. A 2-week washout period from prior allergy medication (if applicable) preceded the baseline assessment.
arm group label: Pataday
arm group type: Experimental
description: Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
intervention type: Drug
intervention name: Olopatadine hydrochloride ophthalmic solution, 0.2%
arm group label: Pataday
other name: PATADAY®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christine Sindt, OD, FAAO
role: Principal Investigator
affiliation: University of Iowa
last name: Pam Kaur, MS PhD
role: Study Director
affiliation: Alcon Research
facility: 
country: United States
responsible party type: Sponsor
mesh term: Conjunctivitis
mesh term: Conjunctivitis, Allergic
mesh term: Olopatadine Hydrochloride
mesh term: Ophthalmic Solutions
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The lack of concurrent control made it difficult to discriminate changes caused by PATADAY® from that caused by other factors, such as observer or patient expectation. Open-labeled design increased the bias from the observer or patient expectation.
point of contact: 