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To evaluate the efficacy and safety of a 7-day regimen of ofloxacin otic 0.3% solution administered once daily to treat otitis externa (OE).Methods: This was an open-label, multicenter, multinational study (involving 58 sites in the U.S. and Central America). Ofloxacin otic 0.3% solution was administered once daily for the treatment of OE in patients over 6.0 months of age with stable or exacerbating OE of more than 2-weeks' duration. Five drops were instilled once daily in each infected ear of 196 patients aged 6.1 months to 12 years (mean Ϯ SD ϭ 8.1 Ϯ 3.3 years), and 10 drops in the ears of 294 patients 13 years and older (35.6 Ϯ 16.0 years). Secretion or exudate specimens were obtained for microbiological analysis.Results: After 7 days of therapy, 298 of 439 clinically evaluable patients (67.9%) were considered cured and 121 (27.6%) clinically improved. At a follow-up visit 710 days later, 398 (90.7%) were considered clinically cured. Forty-three bacterial species were isolated from 253 patients who were clinically and microbiologically evaluable. Overall pathogen eradication rate was 95.7%. The most commonly isolated pathogen, Pseudomonas aeruginosa, was eradicated in 153/158 patients (96.8%). Staphylococcus aureus was eradicated in 31/32 patients (96.9%). No serious adverse events occurred during the study. The most commonly reported nonserious adverse event (11.2% of patients) was a transient increase in earache.Conclusion: Ofloxacin otic 0.3% solution is a safe and effective treatment for OE when administered once daily for 7 days.

The EACC is a rare disease with hyperproliferation and destructive growth into the adjacent structures. Downregulation of ␤-catenin (key component of the zonula adherens) is a pivotal factor for loose tissue integrity and invasiveness. TGF-␤1 was reported to decrease ␤-catenin in mammary epithelium. Here, we investigate the abrogation of TGF-␤1 and ␤-catenin expression in EACC culture cells.Methods: Cultured EACC-specimens were incubated with 6 mol TGF-␤1 antisense. After 48 hours, expression of ␤-catenin was determined by means of immunohistochemistry.Results: The cells showed an increased mural reactivity to ␤-catenin. Intracellular reactivity was unchanged. The untreated cells showed loss of ␤-catenin expression at the membranes. Conclusion:The predominant membranous location after treatment with TGF-␤1 antisense suggests increased tendency of the cells for tissue formation and strong cell-cell adhesion rather than migratory and invasive character, thus, TGF-␤1 antisense application as a useful therapeutical strategy.Significance: Abrogation of TGF-␤1 as a useful therapeutical strategy for the treatment of EACC.