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Trial record 91 of 433 for:    OTITIS

Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2

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ClinicalTrials.gov Identifier: NCT02436304
Recruitment Status : Completed
First Posted : May 6, 2015
Results First Posted : August 28, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).

Condition or disease Intervention/treatment Phase
Otitis Media With Effusion in Children Otitis Media Recurrent Drug: EXE844 Sterile Otic Suspension, 0.3% Procedure: Tympanostomy Tube Insertion Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of EXE844 Otic Suspension in the Treatment of Otitis Media at Time of Tympanostomy Tube Insertion
Actual Study Start Date : June 19, 2015
Actual Primary Completion Date : August 4, 2016
Actual Study Completion Date : August 4, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
Experimental: EXE844 for 7 Days + Tubes
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion
Drug: EXE844 Sterile Otic Suspension, 0.3%
Procedure: Tympanostomy Tube Insertion
Surgical procedure for treating pediatric cases of recurrent or chronic otitis media

Experimental: EXE844 for 3 Days + Tubes
EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
Drug: EXE844 Sterile Otic Suspension, 0.3%
Procedure: Tympanostomy Tube Insertion
Surgical procedure for treating pediatric cases of recurrent or chronic otitis media

Active Comparator: Tubes Only
Bilateral myringotomy and tympanostomy tube insertion
Procedure: Tympanostomy Tube Insertion
Surgical procedure for treating pediatric cases of recurrent or chronic otitis media




Primary Outcome Measures :
  1. Percentage of Subjects With Sustained Clinical Cure at Day 8 [ Time Frame: Day 8 ]
    Sustained clinical cure was defined as the absence of otorrhea in the study ear at Day 8 (end of treatment (EOT)) per the Investigator assessment. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).


Secondary Outcome Measures :
  1. Percentage of Subjects With Microbiological Success at Day 14 [ Time Frame: Day 14 ]
    Microbiological success was attained if all pretherapy bacteria were absent in the study ear for the test-of-cure (TOC) specimen, which was presumed a success for subjects with no otorrhea at Day 14. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).

  2. Time to Cessation of Otorrhea [ Time Frame: Up to Day 14 ]
    The time to cessation of otorrhea in the enrolled ear(s) was calculated as the number of days from the day of surgery to the absence of otorrhea (ie, no discharge) as reported by the parent/caregiver. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).



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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and eligible for bilateral myringotomy and tympanostomy tube insertion.
  • Suspected bacterial infection at time of surgery in at least 1 ear.
  • Willing to refrain from water immersion of the ears following surgery without the use of adequate ear protection during swimming, bathing, showering and other water-related activities.
  • Legally Authorized Representative (LAR) must read and sign the informed consent.
  • Parent or caregiver must agree to comply with the requirements of the study and administer study medication as directed, complete required study visits, and comply with the protocol.
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Previous otologic or otologic-related surgery within the past 30 days or ongoing complications.
  • Middle ear pathology in either ear other than otitis media.
  • Current acute otitis externa (AOE), malignant otitis externa (MOE) or other conditions which could interfere with evaluation of the study drug.
  • Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study based upon assessment by the Investigator.
  • Known or suspected allergy or hypersensitivity to quinolones or other active or inactive ingredients present in the medications to be used in the study.
  • Other protocol-specified exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02436304


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Clinical Manager, Ophtha-GCRA Alcon, A Novartis Division

Additional Information:
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02436304     History of Changes
Other Study ID Numbers: EXE844b-C002
First Posted: May 6, 2015    Key Record Dates
Results First Posted: August 28, 2017
Last Update Posted: July 2, 2018
Last Verified: July 2017
Additional relevant MeSH terms:
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Otitis
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases