Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01535560|
Recruitment Status : Completed
First Posted : February 17, 2012
Results First Posted : December 10, 2013
Last Update Posted : December 10, 2013
|Condition or disease||Intervention/treatment||Phase|
|Acute Otitis Externa||Drug: AL-60371, 0.3% otic suspension Drug: AL-60371 Vehicle||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||589 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 :||April 2012|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
Drug: AL-60371, 0.3% otic suspension
Investigational otic suspension intended for the treatment of acute otitis externa
Placebo Comparator: Vehicle
AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
Drug: AL-60371 Vehicle
Inactive ingredients used as placebo
- 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. Proportion of patients is reported as percentage of participants.
- Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit [ Time Frame: Day 11 ]Microbiological success was considered attained if all pre-therapy bacteria were absent from the exit otic specimen. The presence of fungi and/or yeast was not considered in the determination of microbiological success. Proportion of patients is reported as a percentage of participants.
- Median Time (in Days) to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guadian Via the Telephone Diary [ Time Frame: Time to event (Day 1 to Day 11) ]Cessation of ear pain was defined as occurring the first time point that ear pain was absent (morning or evening) and did not reoccur in any subsequent diary entries.
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): NCT01535560
|Study Director:||Sally Schieb||Alcon Research|