Expired Study
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Fort Worth, Texas 76134


Purpose:

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).


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.


NCT ID:

NCT02432105


Primary Contact:

Study Director
Steve Burmaster, PhD
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 20, 2017

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