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

• Status: Terminated
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: BB 1101; Ciprofloxacin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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.