Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes
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|ClinicalTrials.gov Identifier: NCT01908803|
Recruitment Status : Terminated (Management decision)
First Posted : July 26, 2013
Results First Posted : September 24, 2015
Last Update Posted : December 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Otitis Media||Drug: AL-60371/AL-817 otic suspension Drug: Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Proof of Concept of Single Application of AL-60371/AL-817 Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes Compared to CIPRODEX® (BID for 7 Days)|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
AL-60371/AL-817 otic suspension, 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
Drug: AL-60371/AL-817 otic suspension
Active Comparator: CIPRODEX
Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension, 4 drops in affected ear(s) twice daily through tympanostomy tube for 7 days
Drug: Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension
- Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit [ Time Frame: Day 3 post-treatment up to Day 8 or Early Exit ]A sustained clinical cure at Day 3 was attained if otorrhea was absent at the Day 3 visit and continued to be absent through the last study visit (Day 8 or Early Exit). Proportion of subjects is reported as a percentage.
- Proportion of Subjects With Microbiological Success at the Day 8 Visit [ Time Frame: Day 8 ]Microbiological success was attained if all pre-therapy bacteria were absent in the Day 8 specimen. In a subject with no otorrhea at Day 8, eradication of pre-therapy bacteria was presumed and the subject was considered a microbiological success.
- Median Time (in Days) to Cessation of Otorrhea [ Time Frame: Time to event, up to Day 8 ]Median time (in days) to the cessation of otorrhea (ie, otorrhea was absent) was calculated as the number of days from the Day 1 (Visit 1) to the absence of otorrhea in the affected ear(s) as recorded by the parent/guardian via the twice-daily diary. Cessation of otorrhea was defined as ending on the first day that otorrhea was absent from the affected ear(s) and remained absent for any/all 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): NCT01908803
|Study Director:||Clinical Manager, GCRA, Pharma||Alcon Research|