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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Assuta Hospital Systems.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Assuta Hospital Systems
ClinicalTrials.gov Identifier:
NCT01584271
First received: April 5, 2012
Last updated: July 7, 2013
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Acute Otitis Externa
Device: Natural Ear Comfort(TM), a botanical ear drops product
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Assuta Hospital Systems:

Primary Outcome Measures:
  • Ear Comfort(TM) kills pain in AOE patients within how many hours? [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Does Ear Comfort(TM) heal the inflamation in AOE patients? [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 75
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01584271

Locations
Israel
"Maccabi" Clinic Recruiting
Gedera, Israel
Contact: Dan Guttman, MD    972 52 7777730    dan1966@netvision.net.il   
Principal Investigator: Dan Guttman, ENT MD         
Sponsors and Collaborators
Assuta Hospital Systems
Investigators
Principal Investigator: Dan Guttman, MD Maccabi Healthcare Services, Israel
  More Information

No publications provided

Responsible Party: Assuta Hospital Systems
ClinicalTrials.gov Identifier: NCT01584271     History of Changes
Other Study ID Numbers: 2011058
Study First Received: April 5, 2012
Last Updated: July 7, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Assuta Hospital Systems:
AOE
Ear Comfort
Dex Otic
Otidin

Additional relevant MeSH terms:
Otitis Externa
Otitis
Ear Diseases
Otorhinolaryngologic Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014