Overview

SVT-15652 Otic Solution for the Treatment of Otomycosis

Status:
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.