Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT01027494
Eligibility 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
4 Years
Study:
NCT01027494
Study Brief:
Protocol Section:
NCT01027494