<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03802903</url>
  </required_header>
  <id_info>
    <org_study_id>3126001</org_study_id>
    <nct_id>NCT03802903</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Remo-Wax for Removal of Impacted Earwax</brief_title>
  <acronym>Remo-Wax</acronym>
  <official_title>Efficacy and Safety of Remo-Wax for Removal of Impacted Earwax; an Open, Single-arm, Non-randomised, Multicentre Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Orion Corporation, Orion Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Orion Corporation, Orion Pharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study evaluates if Remo-Wax ear drops can soften impacted earwax.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open, single-arm multicentre study to confirm the efficacy and safety of a&#xD;
      commercially available Remo-Wax ear drops containing allantoin for dissolving and removing&#xD;
      impacted earwax. Subjects that qualify for enrollment and provide informed consent wil be&#xD;
      treated with topical earwax softening product.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 12, 2019</start_date>
  <completion_date type="Actual">April 29, 2019</completion_date>
  <primary_completion_date type="Actual">April 29, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tympanic membrane visuality</measure>
    <time_frame>20-60 minutes</time_frame>
    <description>Tympanic membrane will be assessed in five grades of occlusion's severity after each treatment application.&#xD;
Normal - insignificant earwax present, Minimal - minimal impacted cerumen in ear canal, Mild - some impacted cerumen in ear canal, Moderate - moderate impacted cerumen in ear canal, Severe - excessive impacted cerumen in ear canal</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Cerumen Impaction of Both Ears</condition>
  <arm_group>
    <arm_group_label>Remo-Wax</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test product will be applied into ear canal for 20-60 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Remo-Wax</intervention_name>
    <description>topical treatment</description>
    <arm_group_label>Remo-Wax</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written informed consent obtained.&#xD;
&#xD;
          2. Male or female patients over 1 year old who have cerumen impaction.&#xD;
&#xD;
          3. Presence of excessive or impacted cerumen [excessive or impacted cerumen is identified&#xD;
             as causing partial (&gt; 50%) or complete occlusion of at least one ear canal when&#xD;
             attempting to visualize the tympanic membrane.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypersensitivity to any product ingredient(s) or history of anaphylactic/anaphylactoid&#xD;
             reactions.&#xD;
&#xD;
          2. History of tympanic membrane perforation, tympanostomy tubes, or otitis externa in the&#xD;
             previous 6 months.&#xD;
&#xD;
          3. External ear infection.&#xD;
&#xD;
          4. Middle ear infection&#xD;
&#xD;
          5. Past ear surgery.&#xD;
&#xD;
          6. Otorrhea.&#xD;
&#xD;
          7. Temporal bone neoplasm.&#xD;
&#xD;
          8. Presence of known or suspected mastoiditis.&#xD;
&#xD;
          9. Presence of a condition or abnormality that in the opinion of the Investigator would&#xD;
             compromise the safety of the patient or the quality of the data (e.g. ear eczema or&#xD;
             seborrhoea, ear canal stenosis, exostoses).&#xD;
&#xD;
         10. Deafness in the contralateral ear (single sided deafness).&#xD;
&#xD;
         11. Use of any ototopical drug or cerumen-removal product (with the exception of water or&#xD;
             physiologic saline) during the preceding 3 days.&#xD;
&#xD;
         12. Use of hearing aids.&#xD;
&#xD;
         13. Participation in another drug study within 60 days prior to the start of the present&#xD;
             study.&#xD;
&#xD;
         14. Predictable poor compliance or inability to communicate well with the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>LOR Clinic</name>
      <address>
        <city>Vilnius</city>
        <zip>LT-06122</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Lithuania</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>May 14, 2019</last_update_submitted>
  <last_update_submitted_qc>May 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tooth, Impacted</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03802903
org study id: 3126001
nct id: NCT03802903
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study evaluates if Remo-Wax ear drops can soften impacted earwax.
This is an open, single-arm multicentre study to confirm the efficacy and safety of a
      commercially available Remo-Wax ear drops containing allantoin for dissolving and removing
      impacted earwax. Subjects that qualify for enrollment and provide informed consent wil be
      treated with topical earwax softening product.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tympanic membrane visuality
time frame: 20-60 minutes
description: Tympanic membrane will be assessed in five grades of occlusion's severity after each treatment application.
Normal - insignificant earwax present, Minimal - minimal impacted cerumen in ear canal, Mild - some impacted cerumen in ear canal, Moderate - moderate impacted cerumen in ear canal, Severe - excessive impacted cerumen in ear canal
arm group label: Remo-Wax
arm group type: Experimental
description: Test product will be applied into ear canal for 20-60 minutes.
intervention type: Device
intervention name: Remo-Wax
description: topical treatment
arm group label: Remo-Wax
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
healthy volunteers: No
facility: 
country: Lithuania
responsible party type: Sponsor
mesh term: Tooth, Impacted