A Phase 1 interventional study of Travoprost ophthalmic solution, 0.004% (new formulation) in Glaucoma and Ocular Hypertension, sponsored by Alcon Research. Completed. Open to participants aged 2 Months to 17 Years. Per ClinicalTrials.gov, last updated 2016-04-01.
Sponsored by Alcon Research · Phase 1, Interventional, and Treatment
The purpose of this study was to assess the safety and describe the steady-state plasma pharmacokinetic (PK) profiles of Travoprost ophthalmic solution, 0.004% (new formulation) following a once daily administration for 7 days in pediatric glaucoma or ocular hypertension patients.
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This study's enrollment of 25 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
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Exclusion Criteria:
Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
Drug: Travoprost ophthalmic solution, 0.004% (new formulation)
Travoprost ophthalmic solution, 0.004%, new formulation
Maximum Observed Travoprost Free Acid Plasma Concentration (Cmax)
Travoprost free acid plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Cmax was calculated for each participant with at least 1 quantifiable time point.
Time frame: Day 7, Up to 80 minutes postdose
Time to Reach Cmax (Tmax)
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Tmax was calculated for each participant with at least 1 quantifiable time point.
Time frame: Day 7, Up to 80 minutes postdose
Time to Last Measurable Concentration (Tlast)
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Tlast was calculated for each participant with at least 1 quantifiable time point.
Time frame: Day 7, Up to 80 minutes postdose
Area Under the Analyte Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point [AUC(0-tlast)]
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). AUC(0-tlast) was calculated for each participant with at least 2 quantifiable time points.
Time frame: Day 7, Up to 80 minutes postdose
Area Under the Analyte Plasma Concentration-time Curve Over the Dosing Interval (Inf)[AUC(0-∞)]
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). AUC(0-∞) was calculated for each participant with at least 3 quantifiable time points.
Time frame: Day 7, Up to 80 minutes postdose
Half-life (t½)
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). T½ was calculated for each participant with at least 3 quantifiable time points.
Time frame: Day 7, Up to 80 minutes postdose
Participants were recruited from 4 investigational centers located in the US, 1 located in France, 1 located in Spain, and 1 located in Saudi Arabia.
| Milestone | Travoprost |
|---|---|
| Started | 25 |
| Completed | 25 |
| Not completed | 0 |
Travoprost free acid plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Cmax was calculated for each participant with at least 1 quantifiable time point.
| ng/mL | Travoprost |
|---|---|
| Overall (n=11) | 0.0256 ± 0.0158 |
| 2 mo to < 3 years (n=2) | 0.0471 ± 0.0105 |
| 3 to <12 years (n=6) | 0.0258 ± 0.0128 |
| 12 to <18 years (n=3) | 0.0109 ± 0.000046 |
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Tmax was calculated for each participant with at least 1 quantifiable time point.
| hours | Travoprost |
|---|---|
| Overall (n=11) | 0.25 ± 0.15 |
| 2 mo to <3 years (n=2) | 0.26 ± 0.11 |
| 3 to <12 years (n=6) | 0.17 ± 0.00 |
| 12 to <18 years (n=3) | 0.39 ± 0.26 |
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Tlast was calculated for each participant with at least 1 quantifiable time point.
| hours | Travoprost |
|---|---|
| Overall (n=11) | 0.42 ± 0.35 |
| 2 mo to <3 years (n=2) | 0.34 ± 0.01 |
| 3 to <12 years (n=6) | 0.46 ± 0.47 |
| 12 to <18 years (n=3) | 0.39 ± 0.26 |
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). AUC(0-tlast) was calculated for each participant with at least 2 quantifiable time points.
| ng*hr/mL | Travoprost |
|---|---|
| Overall (n=6) | 0.0116 ± 0.0099 |
| 2 mo to <3 years (n=2) | 0.0101 ± 0.0014 |
| 3 to <12 years (n=4) | 0.0123 ± 0.0127 |
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). AUC(0-∞) was calculated for each participant with at least 3 quantifiable time points.
| ng*hr/mL | Travoprost |
|---|---|
| Overall (n=1) | 0.0389 ± NA |
| 3 to <12 years (n=1) | 0.0389 ± NA |
Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). T½ was calculated for each participant with at least 3 quantifiable time points.
| hours | Travoprost |
|---|---|
| Overall (n=1) | 0.53 ± NA |
| 3 to <12 years (n=1) | 0.53 ± NA |
Collected over Adverse events (AEs) were collected for the duration of the study (6 months). This analysis group includes all participants who received study drug.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Travoprost | — | 1/25 (4%) | 0/25 (0%) |
| Event | Travoprost |
|---|---|
| TrabeculectomySurgical and medical procedures | 1/25 |
This analysis population includes all enrolled participants.
| Age, Continuous(years) | Travoprost |
|---|---|
| Mean | 9.9 ± 5.0 |
| Sex: Female, Male(Participants) | Travoprost |
|---|---|
| Female | 12 |
| Male | 13 |
No study locations are listed for this record.
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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