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)
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Ear Comfort(TM) kills pain in AOE patients within how many hours?
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Ear Comfort(TM) kills pain in AOE patients within how many hours?
Time Frame: 12 months
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 Outcomes
- Does Ear Comfort(TM) heal the inflamation in AOE patients?(12 months)