SVT-15652 Otic Solution for the Treatment of Otomycosis.

Otomycosis Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03686397
• Other study ID #: CLEAR-2
• Status: Completed
• Phase: Phase 3
• Start date: June 9, 2020
• Est. completion date: October 19, 2021

Study information

• Verified date: November 2022
• Source: Salvat
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: October 19, 2021
• Est. primary completion date: October 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Otomycosis

Intervention

Drug:
• SVT-15652
1 vial twice daily
• Placebo
1 vial twice daily

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Salvat

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic Cure (Clinical and Mycological Cure)	Percentage of subjects with therapeutic cure	Test of cure on day 24