<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/NCT03025945</url>
  </required_header>
  <id_info>
    <org_study_id>CME and nepafenac 0.3%</org_study_id>
    <nct_id>NCT03025945</nct_id>
  </id_info>
  <brief_title>Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo</brief_title>
  <official_title>Pseudophakic Cystoid Macular Edema Prevention and Risk Factors; Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intuor Technologies, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Intuor Technologies, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, randomized, double-masked, placebo-controlled clinical study to define the&#xD;
      effective use of a topical non-steroidal anti-inflammatory drug added to topical steroid use&#xD;
      after uncomplicated phacoemulsification for the prevention of pseudophakic cystoid macular&#xD;
      edema.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <phase>N/A</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative Clinical Findings of Cystoid Macular Edema</measure>
    <time_frame>6 weeks</time_frame>
    <description>post-operative macular volume (mm)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">662</enrollment>
  <condition>Cystoid Macular Edema</condition>
  <arm_group>
    <arm_group_label>nepafenac 0.3%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>nepafenac 0.3% ophthalmic solution dosed once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline Solution</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nepafenac 0.3%</intervention_name>
    <arm_group_label>nepafenac 0.3%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline Solution</intervention_name>
    <arm_group_label>Saline Solution</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects, 18 and older subjects with visually significant cataracts and were to&#xD;
             undergo phacoemulsification with implantation of an intracapsular positioned&#xD;
             intraocular lens.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous uveitis (&lt;1 year) previous anterior segment intraocular surgery&#xD;
             hypersensitivity or allergy to NSAIDs&#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>Sean McCafferty, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Arizona Eye Consultants</affiliation>
  </overall_official>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>January 14, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <results_first_submitted>October 2, 2018</results_first_submitted>
  <results_first_submitted_qc>December 12, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 14, 2018</results_first_posted>
  <last_update_submitted>December 12, 2018</last_update_submitted>
  <last_update_submitted_qc>December 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2018</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>Macular Edema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nepafenac</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Nepafenac 0.3%</title>
          <description>nepafenac 0.3% ophthalmic solution dosed once daily&#xD;
Nepafenac 0.3%</description>
        </group>
        <group group_id="P2">
          <title>Saline Solution</title>
          <description>sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily&#xD;
Saline Solution</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="331"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="331"/>
                <participants group_id="P2" count="331"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Six hundred and sixty two (662) patients, one thousand eyes (1000), completed the study. 1:1 ratio of control: treatment. Subjects were chosen from patients who had visually significant cataracts and were to undergo phacoemulsification with implantation of an intracapsular positioned intraocular lens.</population>
      <group_list>
        <group group_id="B1">
          <title>Nepafenac 0.3%</title>
          <description>nepafenac 0.3% ophthalmic solution dosed once daily&#xD;
Nepafenac 0.3%</description>
        </group>
        <group group_id="B2">
          <title>Saline Solution</title>
          <description>sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily&#xD;
Saline Solution</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="331"/>
            <count group_id="B2" value="331"/>
            <count group_id="B3" value="662"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>Eyes</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="500"/>
            <count group_id="B2" value="500"/>
            <count group_id="B3" value="1000"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.8" lower_limit="31" upper_limit="94"/>
                    <measurement group_id="B2" value="67.9" lower_limit="39" upper_limit="96"/>
                    <measurement group_id="B3" value="68.3" lower_limit="31" upper_limit="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="182"/>
                    <measurement group_id="B2" value="182"/>
                    <measurement group_id="B3" value="364"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="149"/>
                    <measurement group_id="B2" value="149"/>
                    <measurement group_id="B3" value="298"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Macular volume</title>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.7" spread="0.15"/>
                    <measurement group_id="B2" value="8.75" spread="0.15"/>
                    <measurement group_id="B3" value="8.72" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Post-operative Clinical Findings of Cystoid Macular Edema</title>
        <description>post-operative macular volume (mm)</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nepafenac 0.3%</title>
            <description>nepafenac 0.3% ophthalmic solution dosed once daily&#xD;
Nepafenac 0.3%</description>
          </group>
          <group group_id="O2">
            <title>Saline Solution</title>
            <description>sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily&#xD;
Saline Solution</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Clinical Findings of Cystoid Macular Edema</title>
          <description>post-operative macular volume (mm)</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Eyes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="331"/>
                <count group_id="O2" value="331"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="500"/>
                <count group_id="O2" value="500"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.85" spread="0.13"/>
                    <measurement group_id="O2" value="8.95" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 weeks</time_frame>
      <desc>Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.</desc>
      <group_list>
        <group group_id="E1">
          <title>Nepafenac 0.3%</title>
          <description>nepafenac 0.3% ophthalmic solution dosed once daily&#xD;
Nepafenac 0.3%</description>
        </group>
        <group group_id="E2">
          <title>Saline Solution</title>
          <description>sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily&#xD;
Saline Solution</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="331"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="331"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>drop intolerance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="331"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Sean McCafferty, MD</name_or_title>
      <organization>Arizona Eye Consultants</organization>
      <phone>520-327-3487</phone>
      <email>sjmccafferty66@hotmail.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/NCT03025945
org study id: CME and nepafenac 0.3%
nct id: NCT03025945
lead sponsor: 
has dmc: No
Prospective, randomized, double-masked, placebo-controlled clinical study to define the
      effective use of a topical non-steroidal anti-inflammatory drug added to topical steroid use
      after uncomplicated phacoemulsification for the prevention of pseudophakic cystoid macular
      edema.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Post-operative Clinical Findings of Cystoid Macular Edema
time frame: 6 weeks
description: post-operative macular volume (mm)
arm group label: nepafenac 0.3%
arm group type: Experimental
description: nepafenac 0.3% ophthalmic solution dosed once daily
arm group label: Saline Solution
arm group type: Placebo Comparator
description: sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily
intervention type: Drug
intervention name: Nepafenac 0.3%
arm group label: nepafenac 0.3%
intervention type: Drug
intervention name: Saline Solution
arm group label: Saline Solution
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sean McCafferty, MD
role: Principal Investigator
affiliation: Arizona Eye Consultants
responsible party type: Sponsor
mesh term: Macular Edema
mesh term: Nepafenac
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 