Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)

NCT ID: NCT02539654

Last Updated: 2018-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-17
• Study Completion Date: 2016-06-24

Brief Summary

The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects, immediately after bilateral tympanostomy tube surgery.

Conditions

Otitis Media With Effusion in Children; Otitis Media Recurrent

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

EXE844

EXE844 Sterile Otic Suspension, 0.3%, single ototopical dose (4 drops) in each ear following tympanostomy tube insertion

Group Type: EXPERIMENTAL

EXE844 Sterile Otic Suspension, 0.3%

Intervention Type: DRUG

Tympanostomy Tube Insertion

Intervention Type: PROCEDURE

Interventions

EXE844 Sterile Otic Suspension, 0.3%

Intervention Type: DRUG

Tympanostomy Tube Insertion

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and eligible for bilateral myringotomy and tympanostomy tube insertion;
• Legally Authorized Representative (LAR) must read and sign the informed consent;
• Parent or caregiver must agree to complete the required study visits and comply with the requirements of the study;

Exclusion Criteria

• Menarcheal females;
• Previous otologic or otologic-related surgery within the past 30 days or ongoing complications;
• Existing perforation of the eardrum;
• 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;
• Use of prohibited medications or inadequate washout of any medication including systemic and topical antibiotics, steroids and/or analgesics;
• Weighs less than 8 kg;

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Manager, GCRA, Pharma

Role: STUDY_DIRECTOR

Alcon Research

Locations

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Countries

United States

Other Identifiers

EXE844b-C003

Identifier Type: -

Identifier Source: org_study_id