Trial Outcomes & Findings for Pharmacokinetic and Safety Study of Travoprost 0.004% in Pediatric Glaucoma Patients (NCT NCT01658839)

NCT ID: NCT01658839

Last Updated: 2016-04-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

25 participants

Primary outcome timeframe

Day 7, Up to 80 minutes postdose

Results posted on

2016-04-01

Participant Flow

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.

Twenty-five participants were enrolled and completed the study. This reporting group includes all enrolled participants (25).

Participant milestones

Participant milestones
Measure	Travoprost 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
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetic and Safety Study of Travoprost 0.004% in Pediatric Glaucoma Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Travoprost n=25 Participants 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
Age, Continuous	9.9 years STANDARD_DEVIATION 5.0 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 7, Up to 80 minutes postdose

Population: This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).

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.

Outcome measures

Outcome measures
Measure	Travoprost n=11 Participants 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
Maximum Observed Travoprost Free Acid Plasma Concentration (Cmax) Overall (n=11)	0.0256 ng/mL Standard Deviation 0.0158
Maximum Observed Travoprost Free Acid Plasma Concentration (Cmax) 2 mo to < 3 years (n=2)	0.0471 ng/mL Standard Deviation 0.0105
Maximum Observed Travoprost Free Acid Plasma Concentration (Cmax) 3 to <12 years (n=6)	0.0258 ng/mL Standard Deviation 0.0128
Maximum Observed Travoprost Free Acid Plasma Concentration (Cmax) 12 to <18 years (n=3)	0.0109 ng/mL Standard Deviation 0.000046

PRIMARY outcome

Timeframe: Day 7, Up to 80 minutes postdose

Population: This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).

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.

Outcome measures

Outcome measures
Measure	Travoprost n=11 Participants 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
Time to Reach Cmax (Tmax) Overall (n=11)	0.25 hours Standard Deviation 0.15
Time to Reach Cmax (Tmax) 2 mo to <3 years (n=2)	0.26 hours Standard Deviation 0.11
Time to Reach Cmax (Tmax) 3 to <12 years (n=6)	0.17 hours Standard Deviation 0.00
Time to Reach Cmax (Tmax) 12 to <18 years (n=3)	0.39 hours Standard Deviation 0.26

PRIMARY outcome

Timeframe: Day 7, Up to 80 minutes postdose

Population: This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).

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.

Outcome measures

Outcome measures
Measure	Travoprost n=11 Participants 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
Time to Last Measurable Concentration (Tlast) Overall (n=11)	0.42 hours Standard Deviation 0.35
Time to Last Measurable Concentration (Tlast) 2 mo to <3 years (n=2)	0.34 hours Standard Deviation 0.01
Time to Last Measurable Concentration (Tlast) 3 to <12 years (n=6)	0.46 hours Standard Deviation 0.47
Time to Last Measurable Concentration (Tlast) 12 to <18 years (n=3)	0.39 hours Standard Deviation 0.26

PRIMARY outcome

Timeframe: Day 7, Up to 80 minutes postdose

Population: This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).

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.

Outcome measures

Outcome measures
Measure	Travoprost n=6 Participants 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
Area Under the Analyte Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point [AUC(0-tlast)] 3 to <12 years (n=4)	0.0123 ng*hr/mL Standard Deviation 0.0127
Area Under the Analyte Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point [AUC(0-tlast)] Overall (n=6)	0.0116 ng*hr/mL Standard Deviation 0.0099
Area Under the Analyte Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point [AUC(0-tlast)] 2 mo to <3 years (n=2)	0.0101 ng*hr/mL Standard Deviation 0.0014

PRIMARY outcome

Timeframe: Day 7, Up to 80 minutes postdose

Population: This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).

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.

Outcome measures

Outcome measures
Measure	Travoprost n=1 Participants 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
Area Under the Analyte Plasma Concentration-time Curve Over the Dosing Interval (Inf)[AUC(0-∞)] Overall (n=1)	0.0389 ng*hr/mL Standard Deviation NA Standard deviation was not estimated
Area Under the Analyte Plasma Concentration-time Curve Over the Dosing Interval (Inf)[AUC(0-∞)] 3 to <12 years (n=1)	0.0389 ng*hr/mL Standard Deviation NA Standard deviation was not estimated

PRIMARY outcome

Timeframe: Day 7, Up to 80 minutes postdose

Population: This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).

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.

Outcome measures

Outcome measures
Measure	Travoprost n=1 Participants 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
Half-life (t½) 3 to <12 years (n=1)	0.53 hours Standard Deviation NA Standard deviation was not estimated
Half-life (t½) Overall (n=1)	0.53 hours Standard Deviation NA Standard deviation was not estimated

Adverse Events

Travoprost

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Travoprost n=25 participants at risk 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
Surgical and medical procedures Trabeculectomy	4.0% 1/25 • Adverse events (AEs) were collected for the duration of the study (6 months). This analysis group includes all participants who received study drug. An AE is defined as any untoward medical occurrence in a participant who is administered a study medication, regardless of whether or not the event has a causal relationship with the medication. Reports of AEs were obtained as solicited comments from the study participants and as observations by the study Investigator.

Other adverse events

Adverse event data not reported

Additional Information

Theresa Landry, Project Head, Clinical Trial Management

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER