CompletedPhase 1

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

United States14 participantsStarted 2015-11-17

Plain-language 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.

Who can participate

Age range

6 Months – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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; * Other protocol-specified inclusion criteria may apply. 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; * Other protocol-specified exclusion criteria may apply.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum Analyte Plasma Concentration (Cmax)

Timeframe: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose

Time to Reach Maximum Concentration (Tmax)

Timeframe: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose

Area Under the Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point (AUC0-last)

Timeframe: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose

Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf)

Timeframe: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose

Time to Last Measurable Concentration (Tlast)

Timeframe: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose

Terminal Elimination Half-life (T1/2)

Timeframe: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose

Trial details

NCT IDNCT02539654

SponsorAlcon Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-06-24

Results submitted2017-06-23

View on ClinicalTrials.gov More Otitis Media With Effusion in Children trials

Who can participate

Age range

6 Months – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Maximum Analyte Plasma Concentration (Cmax)

Timeframe: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose

Time to Reach Maximum Concentration (Tmax)

Timeframe: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose

Area Under the Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point (AUC0-last)

Timeframe: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose

Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf)

Timeframe: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose

Time to Last Measurable Concentration (Tlast)

Timeframe: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose

Terminal Elimination Half-life (T1/2)

Timeframe: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose