Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2

• Status: Completed
• Trial end date: 2016-08-04
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).

• Phase: Phase 3
• 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.

• Suspected bacterial infection at time of surgery in at least 1 ear.

• Willing to 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.

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

• Parent or caregiver must agree to comply with the requirements of the study and administer study medication as directed, complete required study visits, and comply with the protocol.

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

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

• Middle ear pathology in either ear other than otitis media.

• 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 based upon assessment by the Investigator.

• Known or suspected allergy or hypersensitivity to quinolones or other active or inactive ingredients present in the medications to be used in the study.

• Other protocol-specified exclusion criteria may apply.