Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% for the Treatment of Acute Otitis Externa

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT01535560

First received: February 15, 2012

Last updated: January 17, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	February 15, 2012
Last Updated Date	January 17, 2013
Start Date ^ICMJE	April 2012
Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 15, 2012)	Clinical Cure [ Time Frame: Day 11 ] [ Designated as safety issue: No ] Clinical cure is attained if the sum of the numerical scores of the 3 signs and symptoms of AOE (tenderness, erythema, and edema) is 0 at Day 11.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01535560 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 15, 2012)	Microbiological Success [ Time Frame: Day 11 ] [ Designated as safety issue: No ] Microbiological success is attained if all pre-therapy bacteria are absent from the exit specimen. Time to Cessation of Ear Pain [ Time Frame: Days ] [ Designated as safety issue: No ] Cessation of ear pain will be defined as occurring on the first time point that ear pain is absent (morning or evening) and does not return for all subsequent diary entries (as reported by the patient or parent/guardian).
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% for the Treatment of Acute Otitis Externa
Official Title ^ICMJE	Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
Brief Summary	The purpose of this study is to evaluate an investigational drug intended to treat acute otitis externa (AOE).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Acute Otitis Externa
Intervention ^ICMJE	Drug: AL-60371, 0.3% Otic Suspension Investigational otic suspension intended for the treatment of acute otitis externa Other: AL-60371 Vehicle Otic suspension with no active ingredients
Study Arm (s)	Experimental: AL-60371 0.3% Four drops, twice daily, to affected ear(s) for 7 days Intervention: Drug: AL-60371, 0.3% Otic Suspension Placebo Comparator: AL-60371 Vehicle Four drops, twice daily, to affected ear(s) for 7 days Intervention: Other: AL-60371 Vehicle
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	549
Completion Date	October 2012
Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: At least 6 months of age. Clinical diagnosis of acute otitis externa (AOE) based on clinical observation and of presumed bacterial origin in at least one ear. Combined numerical score of ≥4 in at least one affected ear at the Day 1 exam for tenderness, erythema, and edema. Agree to refrain from water immersion of the ears during the conduct of the entire study. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Duration of signs or symptoms of AOE greater than 28 days in the affected ear(s) as reported by patient or parent/guardian. Presence of a tympanostomy tube or perforated tympanic membrane in the affected ear(s). Clinically diagnosed otic disease other than AOE (eg,malignant otitis externa) in the affected ear(s). Known or suspected ear infection of yeast, fungal or mycobacterial origin in the affected ear(s). Prior otologic surgery within 6 months of study entry in the affected ear(s). Known or suspected allergy or hypersensitivity to quinolones or other ingredients present in the medications to be used in the study. Patients who use ear plugs, head phones or ear buds and are unwilling to discontinue their use during the study period. Other protocol-defined exclusion criteria may apply.
Gender	Both
Ages	6 Months and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01535560
Other Study ID Numbers ^ICMJE	C-10-019
Has Data Monitoring Committee	No
Responsible Party	Alcon Research
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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