For the treatment of acute otitis externa in patients 6 months of age and older due to Pseudomonas aeruginosa and Staphylococcus aureus
Thermosensitive liquid-to-gel technology
After administration to the external ear canal, OTIPRIO warms and transitions to a gel.
The first and only single‐dose ciprofloxacin otic suspension administered by a healthcare professional in an office setting
- Study design: Phase 3, randomized, controlled, blinded, multicenter study in 262 pediatric and adult patients with unilateral or bilateral acute otitis externa
- The primary endpoint was the proportion of patients with clinical response at Day 8
- Clinical response was defined as the complete absence of signs and symptoms of acute otitis externa (i.e., tenderness, erythema, edema, and otorrhea as determined by the blinded assessor), and no concomitant systemic or topical antibacterial drug (given in the study ear) was taken for any reason at or prior to the study visit