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.

MITT Population: Randomized patients who had positive baseline fungal culture for Aspergillus spp and/or Candida spp

Overall study period (about 4 weeks)

If pre-existing signs and symptoms of otomycosis worsen during the study, this was considered a treatment failure instead of an adverse event.

The adverse events were reviewed in the safety population which included subjects who received at least 1 dose of study medication (subjects could have positive or negative fungal culture at baseline because the results of baseline culture were not available until a few days after starting the study treatment).