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

This study has been terminated.
(Management Decision)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01111877
First received: April 26, 2010
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

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


Condition
Otorrhea

Study Type: Observational

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Incidence of, time to, and relationship of risk factors associated with otorrhea post tympanostomy tube insertion. [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]

Enrollment: 1389
Study Start Date: May 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric patients between the ages of 6 months and 12 years who are undergoing unilateral or bilateral myringotomy with placement of tympanostomy tube.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01111877

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01111877     History of Changes
Other Study ID Numbers: C-09-041
Study First Received: April 26, 2010
Last Updated: January 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
ear tubes
ear drainage
ear infection
ear drops
tympanostomy tubes
Pediatric patients

ClinicalTrials.gov processed this record on April 17, 2014