SVT-15652 Otic Solution for the Treatment of Otomycosis

A Phase III, Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of SVT-15652 Otic Solution Compared to Placebo for the Treatment of Fungal Otitis Externa (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.

Study Overview

• Status: Completed
• Conditions: Otomycosis
• Intervention / Treatment: Drug: SVT-15652; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 217
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • Carolina Ear,Nose and Throat Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SVT-15652; 1 vial twice daily	Drug: SVT-15652; 1 vial twice daily
Placebo Comparator: Placebo; 1 vial twice daily	Drug: Placebo; 1 vial twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutical Cure (Clinical and Mycological Cure)	Number and percentage of subjects with therapeutic cure	Test of cure on day 24

Collaborators and Investigators

• Sponsor: Salvat

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2020
• Primary Completion (Actual): October 25, 2021
• Study Completion (Actual): October 25, 2021

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 25, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Otorhinolaryngologic Diseases; Bacterial Infections and Mycoses; Ear Diseases; Mycoses; Otomycosis
• Other Study ID Numbers: CLEAR-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No