Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes

Inclusion Criteria:

- Parent or guardian: Read and sign the informed consent. When required by the
Institutional Review Board, child must agree to sign an approved assent form;

- Presence of otorrhea (visible by parent or guardian) of 21 days or less in duration;

- Presence of patent tympanostomy tubes;

- Refrain from water immersion of the ears following surgery without the use of
adequate ear protection during swimming, bathing, showering and other water-related
activities;

- Parent or guardian: Agree to comply with the requirements of the study, administer
the study medication as directed, complete required study visits, and comply with the
protocol;

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- NOT otorrhea-free for at least seven days following tympanostomy tube surgery;

- Menarcheal females;

- Previous otologic surgery, except tympanic membrane, within one year of study entry;

- History of/or current acute or chronic non-tube otorrhea (through existing
perforation of the eardrum);

- Current acute otitis externa, malignant otitis externa, or other conditions which
could interfere with evaluation of the study drug;

- Diabetic (controlled or uncontrolled);

- Use of prohibited medications;

- Other protocol-defined exclusion criteria may apply.