Study of Ear Comfort Ear Drops to Treat AOE Cases Compared to DexOtic & Otidin(R) (NCT01584271) | Clinical Trial Compass
UnknownPhase 2
Study of Ear Comfort Ear Drops to Treat AOE Cases Compared to DexOtic & Otidin(R)
Israel75 participantsStarted 2011-07
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ear Comfort(TM) kills pain in AOE patients within how many hours?