Status:
TERMINATED
Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes
Lead Sponsor:
Alcon Research
Conditions:
Acute Otitis Media
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic Suspension relative to ototopical CIPRODEX for sustained clinical cure, microbiological success, and time to cessa...
Detailed Description
The results at the time of the interim analysis met the futility criteria and the study was subsequently stopped.
Eligibility Criteria
Inclusion
- Parent or guardian: Read and sign the informed consent. When required by the Institutional Review Board, child must agree to sign an approved assent form;
- Presence of otorrhea (visible by parent or guardian) of 21 days or less in duration;
- Presence of patent tympanostomy tubes;
- 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;
- Parent or guardian: Agree to comply with the requirements of the study, administer the study medication as directed, complete required study visits, and comply with the protocol;
- Other protocol-defined inclusion criteria may apply.
Exclusion
- NOT otorrhea-free for at least seven days following tympanostomy tube surgery;
- Menarcheal females;
- Previous otologic surgery, except tympanic membrane, within one year of study entry;
- History of/or current acute or chronic non-tube otorrhea (through existing perforation of the eardrum);
- Current acute otitis externa, malignant otitis externa, or other conditions which could interfere with evaluation of the study drug;
- Diabetic (controlled or uncontrolled);
- Use of prohibited medications;
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT01908803
Start Date
December 1 2013
End Date
August 1 2014
Last Update
December 6 2017
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