SVT-15652 Otic Solution for the Treatment of Otomycosis (NCT03686384) | Clinical Trial Compass
CompletedPhase 3
SVT-15652 Otic Solution for the Treatment of Otomycosis
United States217 participantsStarted 2020-02-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Therapeutical Cure (Clinical and Mycological Cure)