Clinical trial NCT01584271: Study of Ear Comfort Ear Drops to Treat AOE Cases Compared to DexOtic & Otidin(R)
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Otitis Externa
Keywords: AOE
Ear Comfort
Dex Otic
Otidin
Lead sponsor: Assuta Hospital Systems
Sponsor class: OTHER
First posted: 2012-04-24
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ear Comfort(TM) kills pain in AOE patients within how many hours?
timeFrame: 12 months
Secondary outcomes:
measure: Does Ear Comfort(TM) heal the inflamation in AOE patients?
timeFrame: 12 months
Other outcomes:
Locations:
city: Gedera
country: Israel
facility: "Maccabi" Clinic
Study officials:
affiliation: Maccabi Healthcare Services, Israel
name: Dan Guttman, MD
role: PRINCIPAL_INVESTIGATOR
References: