Bioequivalence of Two Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspensions in Otitis Media in Children With Tympanostomy Tubes

Inclusion Criteria:

1. Male or female aged 6 months-12 years of age inclusive.

2. Parent or legal guardian has signed informed consent form, which meets all of thecriteria of current FDA regulations.

3. Based on the patient's age, comprehension and communication developmental skills hasprovided assent to participate in an appropriate format.

4. Confirmed insertion of a patent tympanostomy tube(s) in the infected ear(s).

5. Clinical signs and symptoms consistent with acute bacterial otitis media in at leastone ear and a score of at least 2 for otorrhea using the following scale 0=none, 1=mild, 2=moderate, 3=severe, (see Appendix A for rating scale and severitydefinitions).

6. Otorrhea has been present for 21 days or less.

7. The presence of infection confirmed by a positive bacterial culture for the presenceof Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxellacatarrhalis or Pseudomonas aeruginosa. As the results of the bacterial culture willnot be immediately known, patients who meet all the other inclusion/exclusion criteriamay be enrolled in the study pending the results of the bacterial culture.

Exclusion Criteria:

1. Tympanostomy tube placement occurred within 3 days or less of screening visit.

2. Tympanostomy tubes containing silver oxide or silver salts, or T-type tubes.

3. Signs and symptoms of otitis media for longer than 21 days prior to being screened forinclusion in the study.

4. Since the insertion of the tympanostomy tube(s), more than 1 previous episode ofotitis media within the previous 3 months or more than 4 episodes within the previous 12 months.

5. Provided any therapeutic drug treatment for current episode of otitis media within theprevious 14 days.

6. Current or previous history of any otologic surgery other than insertion/removal oftympanostomy tubes in infected ear(s).

7. Clinical diagnosis that suggests current signs or symptoms are not caused by acutebacterial otitis media e.g. otitis externa

8. Clinical diagnosis of malignant otitis externa

9. Mastoid cavities, stenosis, exostosis or tumors of either ear or other noninfectiousdiseases of either ear.

10. Suspected concurrent fungal or viral infection (e.g. herpes simplex) of either ear.

11. Dermatitis of the infected ear such as psoriasis or seborrhea that would complicateevaluations.

12. Any known hypersensitivity to ciprofloxacin or other carboxyquinolone derivatives,dexamethasone or corticosteroids or other ingredients of the formulation.

13. Significant underlying disease such as diabetes, HIV or other immunocompromisedconditions or receiving therapy that may cause patient to be immunocompromised.

14. Significant history or current evidence of chronic infectious disease, systemdisorder, organ disorder or other medical condition that in the Investigator's opinionwould place the study patient at undue risk by participation or could jeopardize theintegrity of the study evaluations.

15. Investigator believes that severity of infection is such that systemic antibioticswould be the preferred treatment option.

16. Use of any systemic antibacterial products or topical antibacterial products in theear(s) within 14 days of screening for the study.

17. Use of any systemic anti-inflammatory products or topical anti-inflammatory productsin the ear(s) (such as corticosteroids and NSAIDs) within 7 days of screening for thestudy.

18. Use of any topical or otic medication in the affected ear within 7 days prior toscreening.

19. Use of any astringents such as vinegar, alcohol or medicated cleansing or swabbing ofthe ear within 48 hours of the baseline bacterial culture swab.

20. Receipt of any drug or device as part of a research study within 30 days prior todosing.

21. Previous participation in this study.