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

Primary Purpose

Acute Otitis Externa

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Natural Ear Comfort(TM), a botanical ear drops product
Sponsored by
Assuta Hospital Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Otitis Externa focused on measuring AOE, Ear Comfort, Dex Otic, Otidin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • "Maccabi" ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

2 Dex-Otic ear drops

3 Ear Comfort(TM) ear drops

1 Otidin(R) ear drops

Arm 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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 5, 2012
Last Updated
July 7, 2013
Sponsor
Assuta Hospital Systems
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1. Study Identification

Unique Protocol Identification Number
NCT01584271
Brief Title
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

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assuta Hospital Systems

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Otitis Externa
Keywords
AOE, Ear Comfort, Dex Otic, Otidin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2 Dex-Otic ear drops
Arm Type
Active Comparator
Arm 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
Arm Title
3 Ear Comfort(TM) ear drops
Arm Type
Experimental
Arm Description
Natural Ear comfort(TM) ear drops contains Chamomile extract and Thyme oil in anhydrous glycerin for pain relief and ear healing.
Arm Title
1 Otidin(R) ear drops
Arm Type
Active Comparator
Arm Description
Otidin(R): Ear drops containing Tetracaine HCL 0.5%; antipyrine 5% in anhydrous glycerin for pain relief in AOE patients.
Intervention Type
Device
Intervention Name(s)
Natural Ear Comfort(TM), a botanical ear drops product
Other Intervention Name(s)
1 local pain killer, 2 antibiotics & steroid anti-inflamatory ear drops, 3 Ear Comfort(TM) botanical ear drops
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ear Comfort(TM) kills pain in AOE patients within how many hours?
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Does Ear Comfort(TM) heal the inflamation in AOE patients?
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Guttman, MD
Organizational Affiliation
Maccabi Healthcare Services, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
"Maccabi" Clinic
City
Gedera
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Guttman, MD
Phone
972 52 7777730
Email
dan1966@netvision.net.il
First Name & Middle Initial & Last Name & Degree
Dan Guttman, ENT MD

12. IPD Sharing Statement

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

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