Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery

An Open-Label, Single Dose, Pharmacokinetic Study of AL-60371 Otic Suspension, 0.3% in Pediatric Subjects Following Tympanostomy Tube Surgery

The purpose of this study is to describe the pharmacokinetics of AL-60371 otic suspension following two posologies of bilateral ototopical doses in pediatric subjects immediately after bilateral tympanostomy tube surgery.

Inclusion Criteria:

• Requires bilateral myringotomy and tympanostomy tube insertion;
• Provides informed consent (parent/legal guardian);
• Signs assent form where applicable (subject);
• Accompanied by parent/legal guardian at each visit;
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Menarcheal females;
• Current or recent history of any disease which, in the opinion of the Principal Investigator, may place the subject at risk or interfere with study;
• Use of excluded medications within one week prior to surgery and for the duration of the study;
• Requires another surgical procedure in addition to the myringotomy;
• Clinically relevant otic condition which, in the opinion of the Principal Investigator, would preclude the safe administration of the study medication;
• Participation in any other investigational study within 30 days before entry into this study or along with this study;
• Known or suspected allergy or hypersensitivity to any active or inactive ingredient in the test article;
• Other protocol-defined exclusion criteria may apply.