Acute Otitis ExternaPhase 2NCT01584271
Study of Ear Comfort Ear Drops to Treat AOE Cases Compared to DexOtic & Otidin(R)
A Phase 2 study testing Natural Ear Comfort(TM), a botanical ear drops product in people with Acute Otitis Externa, run by Assuta Hospital Systems at 1 site in Israel.
Trial 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®. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Otitis Externa
- What is being tested?
- Natural Ear Comfort(TM), a botanical ear drops product
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2011to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
"Maccabi" Clinic
Gedera
Dan Guttman, MD, 972 52 7777730, dan1966@netvision.net.il
Dan Guttman, ENT MD
About this study
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)
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.
Read the 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.
- Conditions
- Acute Otitis Externa
- Being tested
- Natural Ear Comfort(TM), a botanical ear drops product
- Keywords
- AOE, Ear Comfort, Dex Otic, Otidin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural Ear Comfort(TM), a botanical ear drops productDevice
Also called 1 local pain killer, 2 antibiotics & steroid anti-inflamatory ear drops, 3 Ear Comfort(TM) botanical ear drops
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: Device: Natural Ear Comfort(TM), a botanical ear drops product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startJul 2011
- Primary completionAug 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Otitis ExternaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assuta Hospital Systems
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan Guttman, MD, Principal investigator, Maccabi Healthcare Services, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584271
- Sponsor's protocol ID
- 2011058
- Status last verified
- Apr 2012
- First submitted
- 5 Apr 2012
- Last updated
- 9 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01584271
- Acronym / sponsor ID
- 2011058
- Conditions
- Acute Otitis Externa
- Keywords
- AOE, Ear Comfort, Dex Otic, Otidin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assuta Hospital SystemsUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 24 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 Dex-Otic ear drops | Active comparator | Device: Natural Ear Comfort(TM), a botanical ear drops productDex-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 |
| 3 Ear Comfort(TM) ear drops | Experimental | Device: Natural Ear Comfort(TM), a botanical ear drops productNatural Ear comfort(TM) ear drops contains Chamomile extract and Thyme oil in anhydrous glycerin for pain relief and ear healing. |
| 1 Otidin(R) ear drops | Active comparator | Device: Natural Ear Comfort(TM), a botanical ear drops productOtidin(R): Ear drops containing Tetracaine HCL 0.5%; antipyrine 5% in anhydrous glycerin for pain relief in AOE patients. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natural Ear Comfort(TM), a botanical ear drops productAlso: 1 local pain killer, 2 antibiotics & steroid anti-inflamatory ear drops, 3 Ear Comfort(TM) botanical ear dropsEar 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. | Device | 1 Otidin(R) ear drops, 2 Dex-Otic ear drops, 3 Ear Comfort(TM) ear drops |
Primary outcome
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.
1 secondary outcome
Does Ear Comfort(TM) heal the inflamation in AOE patients?
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Guttman, MD principal investigator
Maccabi Healthcare Services, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Natural Ear Comfort(TM), a botanical ear drops product in people with Acute Otitis Externa, run by Assuta Hospital Systems at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ear Comfort(TM) kills pain in AOE patients within how many hours? (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2013.