Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa
Condition: Acute Otitis Externa
MeSH terms: Otitis; Otitis Externa
Intervention: Ciprodex®; EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension
Intervention description: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days; Treatment of acute otitis externa (AOE) when administered twice daily for 7 days
Intervention MeSH terms: Ciprofloxacin; Dexamethasone; Dexamethasone acetate; BB 1101
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 499.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, 6 months of age and over;

          2. Clinically documented AOE consistent with the diagnostic guidelines of the American
             Academy of Otolaryngology-Head and Neck Surgery Foundation in 1 or both ears;

          3. Inflammation and/or edema ≥2 on the AOE scale, and otorrhea and/or tenderness present;

          4. AOE of <4 weeks duration;

          5. Intact tympanic membrane(s) in the treated ear(s);

          6. Willingness to refrain from swimming through the TOC/ Visit 5;

          7. For subjects with AOE associated with hearing aid use, willingness to discontinue the
             use of hearing aid(s) in the affected ear(s) through the TOC/Visit 5;

          8. Ability to complete the study in compliance with the protocol;

          9. For adult subjects, ability to understand and provide written informed consent; and

         10. For pediatric subjects, a parent or legal guardian has provided written informed
             consent; and

         11. For children age 6 and above, ability to understand and provide assent according to
             institutional requirements.

        Exclusion Criteria:

          1. Acute or chronic suppurative otitis media;

          2. Post-tympanostomy tube acute otorrhea;

          3. Malignant otitis externa;

          4. Suspected or overt fungal or viral ear infection;

          5. Congenital abnormalities or obstructive bony exostoses of the external auditory canal
             of the treated ear(s);

          6. Seborrheic dermatitis or other dermatologic conditions of the external auditory canal
             of the treated ear(s) which could confound evaluation;

          7. Mastoiditis or other suppurative infectious or non-infectious disorders of the treated
             ear(s);

          8. Malignant tumors of the external auditory canal of the treated ear(s);

          9. History of otologic surgery of the treated ear(s), with the exception of tympanic
             membrane surgery >6 months prior to Baseline;

         10. Four or more episodes of otitis externa (OE) in the previous year;

         11. Uncontrolled diabetes mellitus;

         12. Immunosuppressive disorder, including known Human Immunodeficiency Virus infection;

         13. Renal insufficiency;

         14. Hepatitis or hepatic insufficiency;

         15. Receipt of systemic antibiotic concurrently or within 72 hours prior to Baseline;

         16. Receipt of topical otic antibiotic within 24 hours prior to Baseline;

         17. Use of systemic corticosteroid concurrently or within 30 days prior to Baseline;

         18. Use of topical otic corticosteroids concurrently or within 7 days prior to Baseline;

         19. Concurrent use of systemic or topical otic nonsteroidal or other anti-inflammatory
             drugs;

         20. Use of topical vinegar, alcohol, or other astringent otic preparations concurrently or
             within 24 hours prior to Baseline;

         21. Pregnancy, planned pregnancy, or lactation;

         22. Known sensitivity or intolerance to quinolone antibacterial agents;

         23. Previous participation in this trial;

         24. Participation in another investigational drug or vaccine trial concurrently or within
             30 days; or

         25. Significant acute or chronic medical, neurologic, or psychiatric illness in the
             subject or parent/guardian that, in the judgment of the Principal Investigator, could
             compromise subject safety, limit the subject's ability to complete the study, and/or
             compromise the objectives of the study.