Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following 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.