Study of Ear Comfort Ear Drops to Treat AOE Cases Compared to DexOtic & Otidin(R)

Assuta Hospital Systems

Status and phase

Unknown

Phase 2

Conditions

Acute Otitis Externa

Treatments

Device: Natural Ear Comfort(TM), a botanical ear drops product

Study type

Interventional

Funder types

Other

Identifiers

NCT01584271

2011058

Details and patient eligibility

About

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.

Full description

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.

Enrollment

75 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with AOE.
AOE patient determined by ear canal obstruction, exudates and pain.
Males and Females between 18 and 65 years of age.
Patients willing to refrain from using any ear drops products for the entire duration of the study. - - Subjects are willing to use the full 4 steps protocol
Written informed consent has been obtained.

Exclusion criteria

Known allergy or sensitivity to Chamomile extract or essential oils.
Injury to tympanic membrane.
Medical or psychiatric conditions that affect the patient's ability to give informed consent, or complete the study.
Pregnant or lactating females.
Use of ear drops or antibiotic or analgesic medications within the last 4 weeks prior to enrolment to the study.
Other known diseases, including severe allergy, chronic liver or kidney disease, malignancy or contagious diseases, such as HIV or hepatitis.
Alcohol or drug abuse, according to assessment by the investigator.
Participation in other clinical trial within the last 30 days.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

75 participants in 3 patient groups

2 Dex-Otic ear drops

Active Comparator group

Description:

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

Treatment:

Device: Natural Ear Comfort(TM), a botanical ear drops product

3 Ear Comfort(TM) ear drops

Experimental group

Description:

Natural Ear comfort(TM) ear drops contains Chamomile extract and Thyme oil in anhydrous glycerin for pain relief and ear healing.

Treatment:

Device: Natural Ear Comfort(TM), a botanical ear drops product

1 Otidin(R) ear drops

Active Comparator group

Description:

Otidin(R): Ear drops containing Tetracaine HCL 0.5%; antipyrine 5% in anhydrous glycerin for pain relief in AOE patients.