A Phase 2 interventional study of Natural Ear Comfort(TM), a botanical ear drops product in Acute Otitis Externa, sponsored by Assuta Hospital Systems. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-07-09.
Sponsored by Assuta Hospital Systems · Phase 2, Interventional, and Treatment
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.
22 studies on the registry are indexed under Otitis Externa; 1 is open to participants now.
This study's planned enrollment of 75 is below the median of 100 across 20 interventional studies indexed under Otitis Externa.
Browse Otitis Externa studies →Assuta Hospital Systems is the lead sponsor of 34 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
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The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Device: Natural Ear Comfort(TM), a botanical ear drops product
Natural Ear comfort(TM) ear drops contains Chamomile extract and Thyme oil in anhydrous glycerin for pain relief and ear healing.
Device: Natural Ear Comfort(TM), a botanical ear drops product
Otidin(R): Ear drops containing Tetracaine HCL 0.5%; antipyrine 5% in anhydrous glycerin for pain relief in AOE patients.
Device: Natural Ear Comfort(TM), a botanical ear drops product
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.
Also known as: 1 local pain killer, 2 antibiotics & steroid anti-inflamatory ear drops, 3 Ear Comfort(TM) botanical ear drops
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.
Time frame: 12 months
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.
Time frame: 12 months
The record gives a start of Jul 2011, a primary completion of Aug 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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Assuta Hospital Systems