Overview

Topical Treatment of Acute Otitis Media Through Tympanostomy Tubes (AOMT) and Its Effect on Microbial Flora

Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this observational study was to evaluate the effects of a topical fluoroquinolone (antibiotic) instilled into the otic (ear) canal to treat Acute Otitis Media through Tympanostomy Tubes (AOMT) on selected bacterial species on the skin near the ear, in the nose, and in the throat.
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Alcon Research
Treatments:
BB 1101
Ciprofloxacin
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Criteria
Inclusion Criteria:

- Six months to less than 5 years of age at time of enrollment;

- Presence of bilateral, patent tympanostomy tubes;

- Otorrhea-free for at least 7 days following tympanostomy tube surgery (healthy group);

- Otorrhea up to and including 21 days in duration in at least one ear at Visit 1
(treatment group);

- Willing to refrain from significant water immersion of both ears without the use of
adequate ear protection during swimming, bathing, showering and other water-related
activities;

- Read and sign informed consent (parent or guardian);

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Ongoing/current therapy as described in protocol;

- Has received any treatment for current AOMT episode (treatment group);

- Otorrhea greater than 21 days in duration immediately prior to Day 1 visit (treatment
group);

- History of or current acute or chronic non-tube otorrhea (through existing perforation
of the eardrum);

- Current acute otitis externa (AOE), or malignant otitis externa (MOE) or other
conditions which could interfere with evaluation of the study drug;

- Known or suspected ear infection of fungal or mycobacterial origin (treatment group);

- History or active herpes simplex, vaccina or varicella infections or overt viral
infection of the tympanic membrane or the external canal;

- Prior otologic surgery, except that confined to the tympanic membrane, within one year
of study entry;

- Diabetes;

- Any current known or suspected infection (other than AOMT) requiring systemic
antimicrobial therapy;

- Known or suspected allergy or hypersensitivity to quinolones;

- Other protocol-defined exclusion criteria may apply.