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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02432105
Other study ID # EXE844b-C001
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 25, 2015
Est. completion date June 15, 2016

Study information

Verified date June 2017
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 470
Est. completion date June 15, 2016
Est. primary completion date June 15, 2016
Accepts healthy volunteers No
Gender All
Age group 6 Months to 12 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
EXE844 Sterile Otic Suspension, 0.3%

Procedure:
Tympanostomy Tube Insertion
Surgical procedure for treating pediatric cases of recurrent or chronic otitis media

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Alcon Research

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Subjects With Sustained Clinical Cure at Day 8 A sustained clinical cure was attained if otorrhea was absent in the study ear at Day 8 (EOT) per the Investigator assessment and continued to be absent through the end of the study. Participants were considered a treatment failure if, at any time during the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward). Day 8
Secondary Percentage of Subjects With Microbiological Success at Day 14 Microbiological success was attained if all pretherapy bacteria were absent in the study ear for the Test-of-Cure (TOC) (Day 14) specimen. Participants were considered a treatment failure if, at any time during the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward). Day 14
Secondary Time to Cessation of Otorrhea Time (in days) to the 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 via the BID diary. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward). Up to Day 14
See also
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Not yet recruiting NCT05545345 - Adjuvant Adenoidectomy for the Treatment of Chronic OME in Children N/A
Withdrawn NCT03347461 - Otiprio Versus Ciprodex Tympanostomy Tube Outcomes Phase 4
Completed NCT02539654 - Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT) Phase 1
Completed NCT02436304 - Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2 Phase 3
Completed NCT06100159 - Short-term Effects of Ventilation Tubes in Children With Chronic Otitis Media With Effusion N/A