Acute Otitis Externa Clinical Trial
Official title:
Phase II 3 Arm Double Blinded Clinical Study Evaluating the Pain Killing and Healing Time of Botanical Ear Drops, Ear Comfort(TM), in Severe External Ear Infection (AOE) Patients, Compared to Dex-Otic(R) and Otidin(R)
Phase II 3 arm double blinded clinical study, to evaluate pain killing and healing time of
Botanical Ear Drops, Ear Comfort™, in Severe External Ear Infection (AOE) patients in
comparison to Dex-Otic® and Otidin®.
Study Outcome (hypothesis): if Ear Comfort™ proves to perform as well as Dex-Otic, then
ENT's and family doctors will have a botanical non-antibiotic product that does not promote
the formation of antibiotic-resistant infections and may be given to anti-biotics sensitive
patients.
Ear comfort™ is pharmacologically stable for at least 3 years on the shelves.
Severe External Ear Infection (AOE) also known as Swimmer's ear, is an abundant microbiological contamination disease of the outer ear canal. It causes severe pains and accumulation of fluids in the ear. In some cases it may compromise the hearing. Swimming in contaminated water or cleaning the ear with a hard subject are only two examples of what may cause AOE. The main Pathogenes causing the disease are Gram negative of which Pseudomonas aeruginosa is the most abundant. Occasionally it is a fungoid contamination with Aspergillus Niger being the most abundant. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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