<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/NCT02216071</url>
  </required_header>
  <id_info>
    <org_study_id>EXL CDOS-300 AOE</org_study_id>
    <nct_id>NCT02216071</nct_id>
  </id_info>
  <brief_title>Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa</brief_title>
  <official_title>A Phase 3, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study of the Comparative Efficacy and Safety of EXL CDOS in Subjects With Acute Otitis Externa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Exela Pharma Sciences, LLC.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Exela Pharma Sciences, LLC.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to demonstrate the clinical therapeutic non-inferiority of EXL&#xD;
      CDOS to commercially available Ciprofloxacin 0.3% and Dexamethasone 0.1% Sterile Otic&#xD;
      Suspension (Ciprodex®, Alcon) in the treatment of acute otitis externa (AOE) when&#xD;
      administered twice daily for 7 days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a Phase 3, multicenter, randomized, double-blind, active-controlled, parallel-group&#xD;
      study in adults and children (age 6 months and older) with a diagnosis of AOE with a 2-day&#xD;
      screening period followed by a 2-week participation period. Subjects were administered study&#xD;
      drug, EXL CDOS or RLD, 4 drops in the affected ear(s) BID for 7 days. The primary endpoint,&#xD;
      the proportion of subjects with a clinical AOE score of 0, was measured at the TOC Visit on&#xD;
      Day 15.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2014</start_date>
  <completion_date type="Actual">August 11, 2015</completion_date>
  <primary_completion_date type="Actual">August 11, 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Clinical Cure of AOE</measure>
    <time_frame>7 days after the completion of therapy; at Day 15 (+/- 1 day)</time_frame>
    <description>The primary efficacy endpoint was the clinical cure of AOE, defined as the proportion of subjects with a clinical AOE score of 0 at the TOC Visit. Subjects with AOE in both ears were considered to have achieved clinical cure of AOE if the clinical AOE score was 0 for both ears. The clinical AOE score was defined as the sum of scores for inflammation and edema (0=absent, 1=mild, 2=moderate, 3=severe) and tenderness and otorrhea (0=absent, 1=present).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Microbiological Cure (MC)</measure>
    <time_frame>7 days after the completion of therapy; at Day 15 (+/- 1 day)</time_frame>
    <description>The secondary efficacy endpoint was the microbiological cure of AOE, defined as the proportion of subjects with microbiological cure at the TOC Visit. Subjects with AOE in both ears were considered to have achieved microbiological cure if microbiological cure was achieved in both ears.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>Each monitoring visit through 15 +/- 1 days</time_frame>
    <description>Safety outcomes evaluated&#xD;
AEs</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">499</enrollment>
  <condition>Acute Otitis Externa</condition>
  <arm_group>
    <arm_group_label>Ciprodex®, RLD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ciprodex®, Otic Suspension, Twice daily for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EXL CDOS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension, Otic Suspension, Twice daily for 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ciprodex®</intervention_name>
    <description>Treatment of acute otitis externa (AOE) when administered twice daily for 7 days</description>
    <arm_group_label>Ciprodex®, RLD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension</intervention_name>
    <description>Treatment of acute otitis externa (AOE) when administered twice daily for 7 days</description>
    <arm_group_label>EXL CDOS</arm_group_label>
    <other_name>Ciprofloxacin 0.3% and Dexamethasone 0.1% Sterile Otic Suspension</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female, 6 months of age and over;&#xD;
&#xD;
          2. Clinically documented AOE consistent with the diagnostic guidelines of the American&#xD;
             Academy of Otolaryngology-Head and Neck Surgery Foundation in 1 or both ears;&#xD;
&#xD;
          3. Inflammation and/or edema ≥2 on the AOE scale, and otorrhea and/or tenderness present;&#xD;
&#xD;
          4. AOE of &lt;4 weeks duration;&#xD;
&#xD;
          5. Intact tympanic membrane(s) in the treated ear(s);&#xD;
&#xD;
          6. Willingness to refrain from swimming through the TOC/ Visit 5;&#xD;
&#xD;
          7. For subjects with AOE associated with hearing aid use, willingness to discontinue the&#xD;
             use of hearing aid(s) in the affected ear(s) through the TOC/Visit 5;&#xD;
&#xD;
          8. Ability to complete the study in compliance with the protocol;&#xD;
&#xD;
          9. For adult subjects, ability to understand and provide written informed consent; and&#xD;
&#xD;
         10. For pediatric subjects, a parent or legal guardian has provided written informed&#xD;
             consent; and&#xD;
&#xD;
         11. For children age 6 and above, ability to understand and provide assent according to&#xD;
             institutional requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute or chronic suppurative otitis media;&#xD;
&#xD;
          2. Post-tympanostomy tube acute otorrhea;&#xD;
&#xD;
          3. Malignant otitis externa;&#xD;
&#xD;
          4. Suspected or overt fungal or viral ear infection;&#xD;
&#xD;
          5. Congenital abnormalities or obstructive bony exostoses of the external auditory canal&#xD;
             of the treated ear(s);&#xD;
&#xD;
          6. Seborrheic dermatitis or other dermatologic conditions of the external auditory canal&#xD;
             of the treated ear(s) which could confound evaluation;&#xD;
&#xD;
          7. Mastoiditis or other suppurative infectious or non-infectious disorders of the treated&#xD;
             ear(s);&#xD;
&#xD;
          8. Malignant tumors of the external auditory canal of the treated ear(s);&#xD;
&#xD;
          9. History of otologic surgery of the treated ear(s), with the exception of tympanic&#xD;
             membrane surgery &gt;6 months prior to Baseline;&#xD;
&#xD;
         10. Four or more episodes of otitis externa (OE) in the previous year;&#xD;
&#xD;
         11. Uncontrolled diabetes mellitus;&#xD;
&#xD;
         12. Immunosuppressive disorder, including known Human Immunodeficiency Virus infection;&#xD;
&#xD;
         13. Renal insufficiency;&#xD;
&#xD;
         14. Hepatitis or hepatic insufficiency;&#xD;
&#xD;
         15. Receipt of systemic antibiotic concurrently or within 72 hours prior to Baseline;&#xD;
&#xD;
         16. Receipt of topical otic antibiotic within 24 hours prior to Baseline;&#xD;
&#xD;
         17. Use of systemic corticosteroid concurrently or within 30 days prior to Baseline;&#xD;
&#xD;
         18. Use of topical otic corticosteroids concurrently or within 7 days prior to Baseline;&#xD;
&#xD;
         19. Concurrent use of systemic or topical otic nonsteroidal or other anti-inflammatory&#xD;
             drugs;&#xD;
&#xD;
         20. Use of topical vinegar, alcohol, or other astringent otic preparations concurrently or&#xD;
             within 24 hours prior to Baseline;&#xD;
&#xD;
         21. Pregnancy, planned pregnancy, or lactation;&#xD;
&#xD;
         22. Known sensitivity or intolerance to quinolone antibacterial agents;&#xD;
&#xD;
         23. Previous participation in this trial;&#xD;
&#xD;
         24. Participation in another investigational drug or vaccine trial concurrently or within&#xD;
             30 days; or&#xD;
&#xD;
         25. Significant acute or chronic medical, neurologic, or psychiatric illness in the&#xD;
             subject or parent/guardian that, in the judgment of the Principal Investigator, could&#xD;
             compromise subject safety, limit the subject's ability to complete the study, and/or&#xD;
             compromise the objectives of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael H Silverman, MD</last_name>
    <role>Study Chair</role>
    <affiliation>BioStrategics Consulting Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Birmingham Pediatric Associates</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desert Clinical Research/Clinical Research Advantage, Inc.</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Clinic of Jonesboro, PA</name>
      <address>
        <city>Jonesboro</city>
        <state>Arkansas</state>
        <zip>72401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NEA Baptist Clinic</name>
      <address>
        <city>Jonesboro</city>
        <state>Arkansas</state>
        <zip>72401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southland Clinical Research Center</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southland Clinical Reseach Center</name>
      <address>
        <city>Bellflower</city>
        <state>California</state>
        <zip>90706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alessi Institute</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Clinical Trials</name>
      <address>
        <city>Buena Park</city>
        <state>California</state>
        <zip>90620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MCS Clinical Trials</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benchmark Research</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinix Health Services of Colorado/Clinical Research Advantage, Inc.</name>
      <address>
        <city>Centennial</city>
        <state>Colorado</state>
        <zip>80112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado ENT &amp; Allergy</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Springs Health Partners/Clinical Research Advantage, Inc.</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Direct Helpers Medical Center</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palm Springs Research Institute</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abel &amp; Buchheim PR, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Integrity Clinical Trials, LLC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatrics &amp; Adolescent Medicine, PA</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urban Family Practice/Clinical Research Advantage</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Professional Research Network of Kansas, LLC</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Horizon Research Group, LLC</name>
      <address>
        <city>Eunice</city>
        <state>Louisiana</state>
        <zip>70535</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Woburn Pediatric Associates</name>
      <address>
        <city>Woburn</city>
        <state>Massachusetts</state>
        <zip>01801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pioneer Clinical Research</name>
      <address>
        <city>Bellevue</city>
        <state>Nebraska</state>
        <zip>68005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center for Nevada, LLC</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ProMetrix Clinical Studies</name>
      <address>
        <city>Morganville</city>
        <state>New Jersey</state>
        <zip>07751</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Whitehouse Station Family Medicine</name>
      <address>
        <city>Whitehouse Station</city>
        <state>New Jersey</state>
        <zip>08889</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asheboro Research Associates</name>
      <address>
        <city>Asheboro</city>
        <state>North Carolina</state>
        <zip>27203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Ear, Nose, and Throat Associates</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sterling Research Group, Ltd</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hometown Urgent Care and Research</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45424</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cyn3rgy Research</name>
      <address>
        <city>Gresham</city>
        <state>Oregon</state>
        <zip>97030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Across America</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gulf Coast Medical Research</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gulf Coast Medical Research</name>
      <address>
        <city>Missouri City</city>
        <state>Texas</state>
        <zip>77459</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benchmark Research</name>
      <address>
        <city>San Angelo</city>
        <state>Texas</state>
        <zip>76904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercury Clinical Research, Inc</name>
      <address>
        <city>Splendora</city>
        <state>Texas</state>
        <zip>77372</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gulf Coast Medical Research</name>
      <address>
        <city>Sugar Land</city>
        <state>Texas</state>
        <zip>77478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ericksen Research &amp; Development</name>
      <address>
        <city>Clinton</city>
        <state>Utah</state>
        <zip>84015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chyrsalis Clinical Research</name>
      <address>
        <city>Saint George</city>
        <state>Utah</state>
        <zip>84790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J. Lewis Research/First Med East</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J. Lewis Research/Foothill Family Clinic South</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pi-Coor Clinical Research, LLC</name>
      <address>
        <city>Burke</city>
        <state>Virginia</state>
        <zip>22015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Research of Charlottesville, LLC</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heugenot Pediatrics, PC</name>
      <address>
        <city>Midlothian</city>
        <state>Virginia</state>
        <zip>23113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zain Research, LLC</name>
      <address>
        <city>Richland</city>
        <state>Washington</state>
        <zip>97030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advance Medical Concepts, PSC</name>
      <address>
        <city>Cidra</city>
        <zip>00739</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Puerto Rico</name>
      <address>
        <city>San Juan</city>
        <zip>00909</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <results_first_submitted>August 13, 2020</results_first_submitted>
  <results_first_submitted_qc>May 27, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 28, 2021</results_first_posted>
  <last_update_submitted>May 27, 2021</last_update_submitted>
  <last_update_submitted_qc>May 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2021</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>Otitis</mesh_term>
    <mesh_term>Otitis Externa</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ciprofloxacin</mesh_term>
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>BB 1101</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ciprodex®, RLD</title>
          <description>Ciprodex®, Otic Suspension, Twice daily for 7 days&#xD;
Ciprodex®: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days</description>
        </group>
        <group group_id="P2">
          <title>EXL CDOS</title>
          <description>EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension, Otic Suspension, Twice daily for 7 days&#xD;
EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension: Treatment of acute otitis externa (AOE) when administered twice daily for 7 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="254"/>
                <participants group_id="P2" count="245"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="239"/>
                <participants group_id="P2" count="233"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <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="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ciprodex®, RLD</title>
          <description>Ciprodex®, Otic Suspension, Twice daily for 7 days&#xD;
Ciprodex®: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days</description>
        </group>
        <group group_id="B2">
          <title>EXL CDOS</title>
          <description>EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension, Otic Suspension, Twice daily for 7 days&#xD;
EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days</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="254"/>
            <count group_id="B2" value="245"/>
            <count group_id="B3" value="499"/>
          </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="33.3" spread="24.50"/>
                    <measurement group_id="B2" value="33.1" spread="23.54"/>
                    <measurement group_id="B3" value="33.2" spread="24.01"/>
                  </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="132"/>
                    <measurement group_id="B2" value="131"/>
                    <measurement group_id="B3" value="263"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="122"/>
                    <measurement group_id="B2" value="114"/>
                    <measurement group_id="B3" value="236"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="166"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="173"/>
                    <measurement group_id="B2" value="160"/>
                    <measurement group_id="B3" value="333"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="233"/>
                    <measurement group_id="B2" value="210"/>
                    <measurement group_id="B3" value="443"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" 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>Puerto Rico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="236"/>
                    <measurement group_id="B2" value="230"/>
                    <measurement group_id="B3" value="466"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinical Cure of AOE</title>
        <description>The primary efficacy endpoint was the clinical cure of AOE, defined as the proportion of subjects with a clinical AOE score of 0 at the TOC Visit. Subjects with AOE in both ears were considered to have achieved clinical cure of AOE if the clinical AOE score was 0 for both ears. The clinical AOE score was defined as the sum of scores for inflammation and edema (0=absent, 1=mild, 2=moderate, 3=severe) and tenderness and otorrhea (0=absent, 1=present).</description>
        <time_frame>7 days after the completion of therapy; at Day 15 (+/- 1 day)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ciprodex®, RLD</title>
            <description>Ciprodex®, Otic Suspension, Twice daily for 7 days&#xD;
Ciprodex®: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days</description>
          </group>
          <group group_id="O2">
            <title>EXL CDOS</title>
            <description>EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension, Otic Suspension, Twice daily for 7 days&#xD;
EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Cure of AOE</title>
          <description>The primary efficacy endpoint was the clinical cure of AOE, defined as the proportion of subjects with a clinical AOE score of 0 at the TOC Visit. Subjects with AOE in both ears were considered to have achieved clinical cure of AOE if the clinical AOE score was 0 for both ears. The clinical AOE score was defined as the sum of scores for inflammation and edema (0=absent, 1=mild, 2=moderate, 3=severe) and tenderness and otorrhea (0=absent, 1=present).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="254"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="190"/>
                    <measurement group_id="O2" value="191"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Microbiological Cure (MC)</title>
        <description>The secondary efficacy endpoint was the microbiological cure of AOE, defined as the proportion of subjects with microbiological cure at the TOC Visit. Subjects with AOE in both ears were considered to have achieved microbiological cure if microbiological cure was achieved in both ears.</description>
        <time_frame>7 days after the completion of therapy; at Day 15 (+/- 1 day)</time_frame>
        <population>The number of participants analyzed represents Bacteria-Positive cohort of subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Ciprodex®, RLD</title>
            <description>Ciprodex®, Otic Suspension, Twice daily for 7 days&#xD;
Ciprodex®: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days</description>
          </group>
          <group group_id="O2">
            <title>EXL CDOS</title>
            <description>EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension, Otic Suspension, Twice daily for 7 days&#xD;
EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Microbiological Cure (MC)</title>
          <description>The secondary efficacy endpoint was the microbiological cure of AOE, defined as the proportion of subjects with microbiological cure at the TOC Visit. Subjects with AOE in both ears were considered to have achieved microbiological cure if microbiological cure was achieved in both ears.</description>
          <population>The number of participants analyzed represents Bacteria-Positive cohort of subjects</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115"/>
                    <measurement group_id="O2" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Adverse Events</title>
        <description>Safety outcomes evaluated&#xD;
AEs</description>
        <time_frame>Each monitoring visit through 15 +/- 1 days</time_frame>
        <population>499 subjects were randomized as the ITT population, 245 in the EXL CDOS arm &amp; 254 in the RLD arm. All were included in the safety population, but randomization was modified for 36 subjects in the EXL CDOS arm and 43 subjects in the RLD arm to account for available supply of study drug, making 252 subjects in the EXL CDOS arm &amp; 247 in the RLD arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Ciprodex®, RLD</title>
            <description>Ciprodex®, Otic Suspension, Twice daily for 7 days&#xD;
Ciprodex®: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days</description>
          </group>
          <group group_id="O2">
            <title>EXL CDOS</title>
            <description>EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension, Otic Suspension, Twice daily for 7 days&#xD;
EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <description>Safety outcomes evaluated&#xD;
AEs</description>
          <population>499 subjects were randomized as the ITT population, 245 in the EXL CDOS arm &amp; 254 in the RLD arm. All were included in the safety population, but randomization was modified for 36 subjects in the EXL CDOS arm and 43 subjects in the RLD arm to account for available supply of study drug, making 252 subjects in the EXL CDOS arm &amp; 247 in the RLD arm.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="247"/>
                <count group_id="O2" value="252"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>499 subjects were randomized as the ITT population, 245 in the EXL CDOS arm &amp; 254 in the RLD arm. All were included in the safety population, but randomization was modified for 36 subjects in the EXL CDOS arm and 43 subjects in the RLD arm to account for available supply of study drug, making 252 subjects in the EXL CDOS arm &amp; 247 in the RLD arm.</desc>
      <group_list>
        <group group_id="E1">
          <title>Ciprodex®, RLD</title>
          <description>Ciprodex®, Otic Suspension, Twice daily for 7 days&#xD;
Ciprodex®: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days</description>
        </group>
        <group group_id="E2">
          <title>EXL CDOS</title>
          <description>EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension, Otic Suspension, Twice daily for 7 days&#xD;
EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="252"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>TMJ Syndrome</sub_title>
                <description>A 41-year-old woman with a history of lupus, was hospitalized with lupus-associated Tempero Mandibular Joint TMJ syndrome with a lupus flare-up at 2 days after beginning study drug treatment. The SAE, which was deemed to be unrelated to study drug.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="252"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="47" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="42" subjects_at_risk="252"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear and labyrinth disorder</sub_title>
                <description>Ear discomfort, Ear pruritus, Otorrhoea, Ear Congestion, Ear haemorrhage, Ear swelling, Eustachian tube dysfunction, Excessive cerumen production, Hearing impaired, Tympanic membrane disorder, Tympanic membrane hyperaemia, Ear pain, External ear diso</description>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="252"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Photophobia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="252"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="252"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>General disorder and administration site conditions</sub_title>
                <description>Pyrexia, Facial pain, Pain</description>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="252"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infections and Infestations</sub_title>
                <description>Otitis externa, Otitis media, Sinusitis, Gastroenteritis viral, Candida infection, Conjuctivitis, Herpes zoster, Localised infection, Nasopharyngitis, Pharyngitis, Sepsis, Upper respiratory tract infection, Ear infection fungal, Fungal infection</description>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="252"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Injury, poisoning and procedural complications</sub_title>
                <description>Arthropod bite, Hand fracture, Overdose, Concussion, Contusion Laceration, Lip Injurey, Skin abrasion</description>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="252"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Heart rate increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="252"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="252"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorders</sub_title>
                <description>Arthralgia, Temporomandibular joint syndrome, Back pain, Musculoskeletal pain</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="252"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Nercous system disorders</sub_title>
                <description>Headache, Dizziness, Hypoaesthesia, Presyncope, Sinus headache</description>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="252"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory, thoracid and mediastinal disorders</sub_title>
                <description>Cough, Dyspnoea, Epistaxis, Oropharyngeal pain, Rhinitis allergic, Rhinorrhoea</description>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="252"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders</sub_title>
                <description>Rash, Dermatitis contact</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="252"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Menarche</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="252"/>
              </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 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>Aruna Koganti, VP Clinical Programs</name_or_title>
      <organization>Exela Pharma Sciences</organization>
      <phone>828-758-5474</phone>
      <email>akoganti@exela.us</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/NCT02216071
org study id: EXL CDOS-300 AOE
nct id: NCT02216071
lead sponsor: 
has dmc: No
The purpose of the study is to demonstrate the clinical therapeutic non-inferiority of EXL
      CDOS to commercially available Ciprofloxacin 0.3% and Dexamethasone 0.1% Sterile Otic
      Suspension (Ciprodex®, Alcon) in the treatment of acute otitis externa (AOE) when
      administered twice daily for 7 days.
This was a Phase 3, multicenter, randomized, double-blind, active-controlled, parallel-group
      study in adults and children (age 6 months and older) with a diagnosis of AOE with a 2-day
      screening period followed by a 2-week participation period. Subjects were administered study
      drug, EXL CDOS or RLD, 4 drops in the affected ear(s) BID for 7 days. The primary endpoint,
      the proportion of subjects with a clinical AOE score of 0, was measured at the TOC Visit on
      Day 15.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants With Clinical Cure of AOE
time frame: 7 days after the completion of therapy; at Day 15 (+/- 1 day)
description: The primary efficacy endpoint was the clinical cure of AOE, defined as the proportion of subjects with a clinical AOE score of 0 at the TOC Visit. Subjects with AOE in both ears were considered to have achieved clinical cure of AOE if the clinical AOE score was 0 for both ears. The clinical AOE score was defined as the sum of scores for inflammation and edema (0=absent, 1=mild, 2=moderate, 3=severe) and tenderness and otorrhea (0=absent, 1=present).
measure: Number of Participants With Microbiological Cure (MC)
time frame: 7 days after the completion of therapy; at Day 15 (+/- 1 day)
description: The secondary efficacy endpoint was the microbiological cure of AOE, defined as the proportion of subjects with microbiological cure at the TOC Visit. Subjects with AOE in both ears were considered to have achieved microbiological cure if microbiological cure was achieved in both ears.
measure: Number of Participants With Adverse Events
time frame: Each monitoring visit through 15 +/- 1 days
description: Safety outcomes evaluated
AEs
arm group label: Ciprodex®, RLD
arm group type: Active Comparator
description: Ciprodex®, Otic Suspension, Twice daily for 7 days
arm group label: EXL CDOS
arm group type: Experimental
description: EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension, Otic Suspension, Twice daily for 7 days
intervention type: Drug
intervention name: Ciprodex®
description: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days
arm group label: Ciprodex®, RLD
intervention type: Drug
intervention name: EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension
description: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days
arm group label: EXL CDOS
other name: Ciprofloxacin 0.3% and Dexamethasone 0.1% Sterile Otic Suspension
criteria: 
gender: All
minimum age: 6 Months
maximum age: N/A
healthy volunteers: No
last name: Michael H Silverman, MD
role: Study Chair
affiliation: BioStrategics Consulting Ltd
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country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Otitis
mesh term: Otitis Externa
mesh term: Ciprofloxacin
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: BB 1101
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