Phase 3
N=118
SVT-15652 Otic Solution for the Treatment of Otomycosis
Otomycosis
Bottom Line
View on ClinicalTrials.gov: NCT03686384 ↗Enrolled (actual)
118
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Therapeutical Cure (Clinical and Mycological Cure) — 48; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SVT-15652 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Salvat
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Therapeutical Cure (Clinical and Mycological Cure) |
48; 10 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03686384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.