SVT-15652 Otic Solution for the Treatment of Otomycosis.

Salvat

Status and phase: Completed; Phase 3

Conditions: Otomycosis

Treatments: Drug: Placebo; Drug: SVT-15652

Study type: Interventional

Funder types: Industry

Identifiers

NCT03686397

CLEAR-2

Details and patient eligibility

About

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.

Enrollment: 194 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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194 participants in 2 patient groups, including a placebo group

SVT-15652

Experimental group

Description:

1 vial twice daily

Treatment:

Drug: SVT-15652

Placebo

Placebo Comparator group

Description:

1 vial twice daily

Treatment:

Drug: Placebo