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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 Dex-Otic ear drops | Active Comparator | Dex-Otic(R) ear drops are used for pain relief and treating ears of AOE patients. It contains: Dexamethasone Sodium Phosphate 1 mg; Neomycin sulfate 5 mg; Polymyxin B sulfate 10,000 units. It |
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| 3 Ear Comfort(TM) ear drops | Experimental | Natural Ear comfort(TM) ear drops contains Chamomile extract and Thyme oil in anhydrous glycerin for pain relief and ear healing. |
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| 1 Otidin(R) ear drops | Active Comparator | Otidin(R): Ear drops containing Tetracaine HCL 0.5%; antipyrine 5% in anhydrous glycerin for pain relief in AOE patients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natural Ear Comfort(TM), a botanical ear drops product | Device | Ear Comfort(TM): active ingredients - Thyme essential oil & Camomile extract. Inactive ingredients: anhydrous glycerin and a small quantity of surfactant. Dex-Otic(R): Dexamethasone sodium phosphate 1mg; neomycin sulfate 5mg; polymixin B sulfate 10,000 units. Inactive ingredients: propylene glycol, sodium acetate anhydrous, phenyl mercuric acetate, purified water. Otidin(R): Tetracaine HCL 0.5%; antipyrine 5% in anhydrous glycerin. |
| Measure | Description | Time Frame |
|---|---|---|
| Ear Comfort(TM) kills pain in AOE patients within how many hours? | Comparing Ear Comfort(TM) botanical ear drops performance in killing pain in AOE patients to Dex-Otic and Otidin Will be measured by Pain Scores on the Visual Analog Scale. The patients will score their pains on a patient's diary document. A professional medical statitician expert will make the anlysis. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Does Ear Comfort(TM) heal the inflamation in AOE patients? | Performance of Ear Comfort(TM) ear drops, Dex-Otic and Otidin in healing AOE patients ear will be measured by: - reducing microbiological load, patient's compliance and ENT expert/s check of the year during the treatment period and 7 days after stopping the treatment. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Guttman, MD | Maccabi Healthcare Services, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Maccabi" Clinic | Recruiting | Gedera | Israel |
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