Otitis Media
Conditions
Keywords
ear tubes, tympanostomy tubes, Otitis Media at the time of Tympanostomy Tube surgery, OMTT
Brief summary
The purpose of this study is to describe the pharmacokinetics of AL-60371 otic suspension following two posologies of bilateral ototopical doses in pediatric subjects immediately after bilateral tympanostomy tube surgery.
Interventions
DRUGAL-60371 otic suspension
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Years
Healthy volunteers
No
Inclusion criteria
* Requires bilateral myringotomy and tympanostomy tube insertion; * Provides informed consent (parent/legal guardian); * Signs assent form where applicable (subject); * Accompanied by parent/legal guardian at each visit; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Menarcheal females; * Current or recent history of any disease which, in the opinion of the Principal Investigator, may place the subject at risk or interfere with study; * Use of excluded medications within one week prior to surgery and for the duration of the study; * Requires another surgical procedure in addition to the myringotomy; * Clinically relevant otic condition which, in the opinion of the Principal Investigator, would preclude the safe administration of the study medication; * Participation in any other investigational study within 30 days before entry into this study or along with this study; * Known or suspected allergy or hypersensitivity to any active or inactive ingredient in the test article; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed analyte plasma concentration (Cmax) | Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose | The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). |
| Time to reach Cmax (Tmax) | Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose | The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). |
| Area under the analyte plasma concentration-time curve to the last quantifiable sampling time point (AUC0-last) | Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose | The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). |
| Area under the concentration-time curve from 0 to infinity (AUC0-∞) | Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose | The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). |
| Time to last measurable concentration (Tlast) | Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose | The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). |
| The terminal elimination half (T½) | Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose | The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). |
Outcome results
None listed