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

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01584271
• Other study ID #: 2011058
• Status: Recruiting
• Phase: Phase 2
• First received: April 5, 2012
• Last updated: July 7, 2013
• Start date: July 2011
• Est. completion date: December 2013

Study information

• Verified date: April 2012
• Source: Assuta Hospital Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Otitis Externa
• Otitis Externa

Intervention

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.

Locations

Country	Name	City	State
Israel	"Maccabi" Clinic	Gedera

Sponsors (1)

Lead Sponsor	Collaborator
Assuta Hospital Systems

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes