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SALVAT: SVT-15652 Otic Solution for the Treatment of 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:

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

Main Exclusion Criteria:

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

For more information please call 502.893.0159 and ask for Research

 

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