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

Alcon

Status and phase

Completed

Phase 1

Conditions

Otitis Media Recurrent

Otitis Media With Effusion in Children

Treatments

Procedure: Tympanostomy Tube Insertion

Drug: EXE844 Sterile Otic Suspension, 0.3%

Study type

Interventional

Funder types

Industry

Identifiers

NCT02539654

EXE844b-C003

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

6 months to 12 years old

Volunteers

No Healthy Volunteers

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.