Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)

• Status: Completed
• Trial end date: 2016-06-24
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects, immediately after bilateral tympanostomy tube surgery.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research

Criteria

Inclusion Criteria:

• Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and eligible for bilateral myringotomy and tympanostomy tube insertion;

• Legally Authorized Representative (LAR) must read and sign the informed consent;

• Parent or caregiver must agree to complete the required study visits and comply with the requirements of the study;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Menarcheal females;

• Previous otologic or otologic-related surgery within the past 30 days or ongoing complications;

• Existing perforation of the eardrum;

• Current acute otitis externa (AOE), malignant otitis externa (MOE) or other conditions which could interfere with evaluation of the study drug;

• Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study;

• Use of prohibited medications or inadequate washout of any medication including systemic and topical antibiotics, steroids and/or analgesics;

• Weighs less than 8 kg;

• Other protocol-specified exclusion criteria may apply.