A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension

Multicentric, Double Blind, Randomized, Parallel Comparative Study Between Ciprofloxacin HCl 2 mg/mL + Hydrocortisone 10 mg/mL Ear Suspension and Cipro HC®, for the Assessment of Efficacy and Safety in Patients With Otitis Externa.

The objective of this study is to compare the efficacy and safety profiles of the test product containing 2 mg/mL ciprofloxacin hydrochloride associated with 10 mg/mL of hydrocortisone with the reference product Cipro HC®, in patients with acute otitis externa.

Phase III, non inferiority, multicentric, controlled, single blind, parallel-group, randomized study.

Population: 224 patients with external otitis , men and women aged between 1 - 70 years.

Primary endpoint: The primary endpoint of this study is the elimination of pain, swelling and otorrhea (cure).

Secondary endpoint: The endpoint will be the identification of the side effects of medication use.

Inclusion Criteria:

• Informed of the nature of the study and given written informed consent;
• Patients with acute otitis externa;
• Intact tympanic membrane.

Exclusion Criteria:

• Known allergy or sensitivity to Ciprofloxacin Hydrochloride and Hydrocortisone;
• Patient has the tympanic membrane not intact;
• Diabetes
• Bilateral Acute Otitis Externa;
• Pregnant or lactating patients;
• Overt fungal Acute Otitis Externa;
• Other diseases of the ear
• Current Infection requiring systemic antimicrobial therapy.
• Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.