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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Acute Otitis Externa
• Intervention / Treatment: Device: Natural Ear Comfort(TM), a botanical ear drops product

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.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Gedera, Israel
    • Recruiting
    • "Maccabi" Clinic
    • Contact: Dan Guttman, MD; Phone Number: 972 52 7777730; Email: dan1966@netvision.net.il
    • Principal Investigator: Dan Guttman, ENT MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2 Dex-Otic ear drops; 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; 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.; Other Names: 1 local pain killer; 2 antibiotics & steroid anti-inflamatory ear drops; 3 Ear Comfort(TM) botanical ear drops
Experimental: 3 Ear Comfort(TM) ear drops; 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; 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.; Other Names: 1 local pain killer; 2 antibiotics & steroid anti-inflamatory ear drops; 3 Ear Comfort(TM) botanical ear drops
Active Comparator: 1 Otidin(R) ear drops; 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.; Other Names: 1 local pain killer; 2 antibiotics & steroid anti-inflamatory ear drops; 3 Ear Comfort(TM) botanical ear drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Assuta Hospital Systems
• Investigators: Principal Investigator: Dan Guttman, MD, Maccabi Healthcare Services, Israel

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): August 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: April 5, 2012
• First Submitted That Met QC Criteria: April 23, 2012
• First Posted (Estimate): April 24, 2012

Study Record Updates

• Last Update Posted (Estimate): July 9, 2013
• Last Update Submitted That Met QC Criteria: July 7, 2013
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: AOE; Ear Comfort; Dex Otic; Otidin
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Externa; Anti-Infective Agents, Local; Anti-Infective Agents; Anti-Bacterial Agents; Carbamide Peroxide
• Other Study ID Numbers: 2011058

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No