NCT01584271

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 24, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 9, 2013

Status Verified

April 1, 2012

Enrollment Period

2.1 years

First QC Date

April 5, 2012

Last Update Submit

July 7, 2013

Conditions

Acute Otitis Externa

Keywords

AOEEar ComfortDex OticOtidin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Does Ear Comfort(TM) heal the inflamation in AOE patients?

    12 months

Study Arms (3)

2 Dex-Otic ear drops

ACTIVE COMPARATOR

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

3 Ear Comfort(TM) ear drops

EXPERIMENTAL

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

1 Otidin(R) ear drops

ACTIVE COMPARATOR

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

Interventions

Natural Ear Comfort(TM), a botanical ear drops productDEVICE

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.

Also known as: 1 local pain killer, 2 antibiotics & steroid anti-inflamatory ear drops, 3 Ear Comfort(TM) botanical ear drops
1 Otidin(R) ear drops2 Dex-Otic ear drops3 Ear Comfort(TM) ear drops

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Maccabi" Clinic

Gedera, Israel

RECRUITING

Study Officials

  • Dan Guttman, MD

    Maccabi Healthcare Services, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2012

First Posted

April 24, 2012

Study Start

July 1, 2011

Primary Completion

August 1, 2013

Study Completion

December 1, 2013

Last Updated

July 9, 2013

Record last verified: 2012-04

Locations

IL(1)