SVT-15652 Otic Solution for the Treatment of Otomycosis.

• Status: Active, not recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Salvat

Criteria

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.