Expired Study
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Fort Worth, Texas 76134


Purpose:

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.


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.


NCT ID:

NCT02539654


Primary Contact:

Study Director
Clinical Manager, GCRA, Pharma
Alcon Research


Backup Contact:

N/A


Location Contact:

Fort Worth, Texas 76134
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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