Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
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|ClinicalTrials.gov Identifier: NCT01535599|
Recruitment Status : Completed
First Posted : February 20, 2012
Results First Posted : June 18, 2014
Last Update Posted : July 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Acute Otitis Externa||Drug: AL-60371, 0.3% Otic Suspension Other: AL-60371 Vehicle||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||768 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
Drug: AL-60371, 0.3% Otic Suspension
Placebo Comparator: Vehicle
AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
Other: AL-60371 Vehicle
Inactive ingredients used as a placebo comparator
- Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit [ Time Frame: Day 11 ]An otoscopic exam was conducted by the physician. Clinical cure was considered attained if the sum of the numerical scores of the 3 signs and symptoms of AOE (tenderness, erythema, and edema) was 0 at Day 11. In this analysis, the clinical cure outcome at Day 11 (TOC) was considered a failure for all pathogen positive patients who did not complete the study (for any reason). Proportion of patients is reported as a percentage.
- Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit [ Time Frame: Day 11 ]Microbiological success was considered attained if all pretherapy bacteria were absent from the exit otic specimen. The presence of fungi and/or yeast was not considered in the determination of microbiological success. In this analysis, the microbiological success value at Day 11 (TOC) was considered a failure for all pathogen positive patients who did not complete the study (for any reason). Proportion of patients is reported as a percentage.
- Median Time to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guardian Via the Telephone Diary [ Time Frame: Time to event, up to Day 11 ]Cessation of ear pain was defined as occurring on the first time point that ear pain was absent (morning or evening) and did not return in any subsequent diary entries. Day 1 was the starting point for this time-to-event analysis. For this analysis, all patients who did not complete the study and ear pain never ceased had their ear pain considered as being present throughout the planned duration of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01535599
|Study Director:||Sally Scheib, Sr. Clinical Project Lead||Alcon Research|