A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months

Inclusion criteria

includes but is not limited to:

• Male and female infants and children aged ≥6 months to ≤24 months
• Diagnosis of Acute Otitis Media (AOM) - moderate to severe bulging of the TM or mild bulging of TM and recent [less than 48 hours] onset of ear pain or intense erythema of the TM
• Score of 5 or more on the 5 question version of AOM-SOS scale1
• Written informed consent by the child's legal guardian and their willingness to ensure that study instructions are followed, all study-related visits are attended, that treatment administration is given, and Parent/Caregiver assessments are recorded according to the study protocol.
• Intact tympanic membrane (TM) in both ears (e.g., no perforation)

Exclusion criteria

includes but is not limited to:

• Allergy to penicillin or cephalosporin
• History or presence of immunodeficiency disorders
• Antimicrobial therapy within the 3 days (i.e., 72 hours) prior to Day 1
• Craniofacial abnormalities (e.g., cleft palate or Down's Syndrome) that may interfere with Eustachian tube function
• Disorders with decreased mucociliary clearance or higher viscosity of the mucous (e.g., cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)
• Clinically relevant blockage of 1 or both nasal passages, as determined by the investigator's medical judgment