Natural History Study of Incidence of Otorrhea Following Tympanostomy Tube Insertion in Children 6 Months to 12 Years

N/ATerminatedNCT01111877

Alcon Research1,389 enrolled

Overview

This study was conducted to describe the time to first incidence of otorrhea post tympanostomy tube insertion.

Study Type

OBSERVATIONAL

Enrollment

1,389

Conditions

Otorrhea

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants must be at least 6 months old and no more than 13 years of age at the time of enrollment scheduled for unilateral or bilateral myringotomy and tympanostomy tube insertion. Patients and/or child must read/sign informed consent and comply with requirement of the study. Exclusion Criteria: * There are no exclusion criteria.

Locations (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

Incidence of, time to, and relationship of risk factors associated with otorrhea post tympanostomy tube insertion.

Time frame: Up to 1 year

Data from ClinicalTrials.gov

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