SVT-15652 Otic Solution for the Treatment of Otomycosis.

A Phase III, Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of SVT-15652 Otic Solution Compared to Placebo for the Treatment of Fungal Otitis Externa (Otomycosis).

Multicenter, randomized, 2-arm parallel-group, double blind, placebo-controlled study in patients suffering from Otomycosis. This study will compare the efficacy and safety of SVT-15652 otic solution to that of Placebo, when administering one vial twice daily during 14 days.

Main Inclusion Criteria:

• At least 18 years of age
• Clinical diagnosis of otomycosis in one or both ears, where topical treatment is indicated.
• Signs/symptoms of pruritus, otalgia and ear fullness.
• Debris or drainage clinically consistent with fungal infection.

Main Exclusion Criteria:

• Known bacterial otitis externa or malignant otitis externa.
• Tympanic perforation, tympanostomy tubes inserted and post mastoid surgery.
• Structural ear anomalies which may difficult the evaluation of the therapeutic response.
• Uncontrolled diabetes mellitus.
• Any infection requiring systemic antimicrobial or systemic antifungal therapy.
• Concomitant medicines that may interfere with the study evaluations.