Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media and Reduction of Ear Pain in Adults With Acute Otitis Media

Exclusion Criteria

• •1. Presence of a perforated TM at Screening or had a perforated TM within 6 months (mo) prior to Screening as determined by medical history
• •2. Subjects with tympanostomy tubes
• •3. Acute or chronic otitis externa
• •4. Chronic otitis media defined as confirmed presence of middle ear effusion for 12 weeks or longer
• •5. Disorders with decreased mucociliary clearance or higher viscosity of the mucous (eg, cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)
• •6. Clinically relevant blockage of 1 or both nasal passages, as determined by the investigator's medical judgment
• •7. Permanent hearing loss irrespective of otitis media
• •8. Subjects with medical conditions that may affect interpretation of the safety or efficacy of study drug as determined by the investigator's medical judgment
• •9. Subjects with craniofacial abnormalities (eg, cleft palate, Down's Syndrome)
• •10. Subjects with erythema of the TM without other evidence of otitis media
• •11. Seborrheic dermatitis involving the affected external ear canal or pinna
• •12. Use of medications with known vasoconstrictive properties (eg, decongestants \[Afrin®, Sudafed®\]) currently or within 2 h prior to Screening