Phase III Efficacy and Safety Study of Miconazole Oil for Otomycosis
brief summary
The goal of this clinical trial is to prove the that miconazole oil works well on fungal infections of the ears, by comparing the drug with a placebo. The researcher or the participants will not know if they are getting the drug or the placebo. The researcher will show the participants how to use the drug or placebo. After 14 days of using the drug or placebo, the participants will be examined by the researcher and graded on how well the drug worked on the ear(s) fungal infection. Participants will also be checked and asked for any bad side effects from the drug or the placebo.
detailed description
The purpose of this study is to gather confirmatory data on the efficacy and safety of 2% miconazole oil after topical otic administration in subjects with otomycosis, and to fully establish evidence of efficacy for miconazole oil compared to the placebo (mineral oil). A 14-day regimen of twice-daily administration of 2% miconazole oil will be compared with the same treatment regimen using the placebo, mineral oil. This study is a randomized, double-blind, parallel-group study to be conducted at up to 8 study centers in the US. An estimated 90 male or female subjects with otomycosis will receive study drug. Subjects will be randomly assigned in a 1:1 ratio within study site to receive miconazole oil or mineral oil for 14 days \[administered as 5 drops per ear at \~30 mg per drop instilled into the external ear canal of the ear(s) affected by otomycosis\]. Both the subject and the investigator and study staff will be blinded as to the contents of the study drug.
The primary efficacy endpoint is:
• Clinical Cure, defined as score of 0 for fungal elements, and for each of the signs/symptoms of pruritus, aural fullness and debris, at the Test of Cure visit.
official title
Randomized, Double-blind, Phase III Study of the Efficacy and Safety of Miconazole Oil, Active Versus Placebo in the Treatment of Otomycosis