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Objective: To compare the efficacy and safety of ciprofloxacin otic solution 0.2% to polymyxin B-neomycin-hydrocortisone (PNH) otic solution in the treatment of acute diffuse otitis externa in children, adolescents, and adults.Methods: This was a randomized, parallel-group, evaluator-blind, active-controlled, multicenter, noninferiority study. The primary efficacy endpoint was clinical cure of otitis symptoms at the test-of-cure (TOC) visit. Clinical cure at the end-of-treatment (EOT) visit and percentages of patients with clinical improvement and resolution and/or improvement of otalgia at EOT and TOC visits were secondary efficacy endpoints.Results: A total of 630 patients were randomized to ciprofloxacin twice daily (n = 318) or PNH 3 times daily (n = 312) for 7 days. Ciprofloxacin was shown to be noninferior to PNH. The percentage of patients with clinical cure at the TOC visit was 86.6% with ciprofloxacin and 81.1% with PNH; the treatment difference was 5.6% in favor of ciprofloxacin (95% CI: -0.9 to 12.1). At the EOT visit, clinical cure was achieved in 70.0% and 60.5% of patients, respectively, with a treatment difference in favor of ciprofloxacin (9.5%, 95 CI: 1.2 to 17.9). In all secondary efficacy variables, ciprofloxacin and PNH showed similar results, including pain duration and resolution. The clinical cure rate for patients with baseline cultures showing P. aeruginosa was 87.5% in the ciprofloxacin group and 78.6% in the PNH group, a treatment difference of 8.9% in favor of ciprofloxacin (95% CI: 0.6 to 17.3); for patients with baseline cultures showing S. aureus, the clinical cure rate was 72.7% for the ciprofloxacin group and 75.9% for the PNH group (treatment difference of 3.1% in favor of PNH, 95% CI: -21.1% to 27.4%). Most adverse events were mild and unrelated to study medication in both treatment groups. A limitation of this study is the assessment of signs and symptoms at baseline and after treatment, which does not provide data to evaluate the interim response.Conclusions: Ciprofloxacin otic solution 0.2% was found to be noninferior to PNH. This efficacy, good tolerability, and ease of administration make ciprofloxacin otic solution 0.2% without a topical steroid an attractive option for the treatment of acute otitis externa. [ABSTRACT FROM AUTHOR]

ABSTRACTObjective:To compare the efficacy and safety of ciprofloxacin otic solution 0.2 to polymyxin B-neomycin-hydrocortisone (PNH) otic solution in the treatment of acute diffuse otitis externa in children, adolescents, and adults.Methods:This was a randomized, parallel-group, evaluator-blind, active-controlled, multicenter, noninferiority study. The primary efficacy endpoint was clinical cure of otitis symptoms at the test-of-cure (TOC) visit. Clinical cure at the end-of-treatment (EOT) visit and percentages of patients with clinical improvement and resolution and/or improvement of otalgia at EOT and TOC visits were secondary efficacy endpoints.Results:A total of 630 patients were randomized to ciprofloxacin twice daily (n 318) or PNH 3 times daily (n 312) for 7 days. Ciprofloxacin was shown to be noninferior to PNH. The percentage of patients with clinical cure at the TOC visit was 86.6 with ciprofloxacin and 81.1 with PNH; the treatment difference was 5.6 in favor of ciprofloxacin (95 CI: −0.9 to 12.1). At the EOT visit, clinical cure was achieved in 70.0 and 60.5 of patients, respectively, with a treatment difference in favor of ciprofloxacin (9.5, 95 CI: 1.2 to 17.9). In all secondary efficacy variables, ciprofloxacin and PNH showed similar results, including pain duration and resolution. The clinical cure rate for patients with baseline cultures showing P. aeruginosawas 87.5 in the ciprofloxacin group and 78.6 in the PNH group, a treatment difference of 8.9 in favor of ciprofloxacin (95 CI: 0.6 to 17.3); for patients with baseline cultures showing S. aureus, the clinical cure rate was 72.7 for the ciprofloxacin group and 75.9 for the PNH group (treatment difference of 3.1 in favor of PNH, 95 CI: −21.1 to 27.4). Most adverse events were mild and unrelated to study medication in both treatment groups. A limitation of this study is the assessment of signs and symptoms at baseline and after treatment, which does not provide data to evaluate the interim response.Conclusions:Ciprofloxacin otic solution 0.2 was found to be noninferior to PNH. This efficacy, good tolerability, and ease of administration make ciprofloxacin otic solution 0.2 without a topical steroid an attractive option for the treatment of acute otitis externa. [ABSTRACT FROM AUTHOR]

A 42 year-old man underwent a nasal septoplasty and awoke with vision of light perception in his right eye. An afferent pupillary defect was noted with a normal fundus examination, normal fluorescein angiography and intact optic canal on imaging studies. A diagnosis of posterior ischaemic optic neuropathy was made. No visual improvement was noted in our case despite treatment with high dose oral steroids. Follow-up showed optic atrophy on fundoscopy and retinal nerve fiber layer thinning on OCT. Visual loss after nasal septoplasty surgery is extremely rare, with few cases reported in the literature. It can occur if the optic canal is fractured, but has been most commonly reported as a complication of intranasal anesthetic injections. Vigorous pressure during injection can overcome arterial pressure causing the injected material to circulate in a retrograde manner via arterial branches and cause ischaemia of the optic nerve. A further possibility is that intranasal injection could cause emboli to enter the optic nerve circulation. Physicians should be aware of this potentially blinding complication after intranasal anesthetic injections. [ABSTRACT FROM AUTHOR]