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

Proof of Concept of Single Application of AL-60371/AL-817 Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes Compared to CIPRODEX® (BID for 7 Days)

The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic Suspension relative to ototopical CIPRODEX for sustained clinical cure, microbiological success, and time to cessation of otorrhea.

The results at the time of the interim analysis met the futility criteria and the study was subsequently stopped.

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.