Clinical Trial Results:
An Open-Label, Pharmacokinetic and Safety Study of Travoprost Ophthalmic Solution, 0.004% in Pediatric Glaucoma or Ocular Hypertension Patients
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Summary
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EudraCT number |
2012-001640-22 |
Trial protocol |
GB BE ES FR |
Global end of trial date |
10 Jul 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Feb 2016
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First version publication date |
05 Aug 2015
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
C-12-009
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01658839 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Alcon Research, Ltd.
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Sponsor organisation address |
6201 South Freeway, Fort Worth, Texas, United States, 76134
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Public contact |
Head, Pharma, GCRA, Alcon Research, Ltd. , +1 8884513937, alcon.medinfo@alcon.com
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Scientific contact |
Head, Pharma, GCRA, Alcon Research, Ltd., +1 8884513937, alcon.medinfo@alcon.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-001271-PIP01-12 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
10 Jul 2013
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
10 Jul 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
10 Jul 2013
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
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% following a once daily administration for 7 days in pediatric glaucoma or ocular hypertension patients.
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Protection of trial subjects |
This study was performed in compliance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice (GCP). A parent/legal guardian (if necessary, a legally authorized representative) provided informed consent, and the child signed an approved assent form when applicable.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
14 Jan 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 1
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Country: Number of subjects enrolled |
United States: 21
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Country: Number of subjects enrolled |
France: 1
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Country: Number of subjects enrolled |
Saudi Arabia: 2
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Worldwide total number of subjects |
25
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EEA total number of subjects |
2
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
4
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Children (2-11 years) |
9
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Adolescents (12-17 years) |
12
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
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. | ||||||
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Pre-assignment
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Screening details |
This reporting group includes all enrolled participants (25). | ||||||
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Period 1
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Period 1 title |
Overall (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
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Arms
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Arm title
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Travoprost | ||||||
Arm description |
Travoprost ophthalmic solution, 0.004%, one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Travatan
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Eye drops
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Routes of administration |
Topical use
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Dosage and administration details |
One drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
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Baseline characteristics reporting groups
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Reporting group title |
Overall
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Travoprost
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Reporting group description |
Travoprost ophthalmic solution, 0.004%, one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days | ||
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End point title |
Maximum Observed Travoprost Free Acid Plasma Concentration (Cmax) [1] | ||||||||||||||||
End point description |
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. Here, n=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).
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End point type |
Primary
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End point timeframe |
Day 7, Up to 80 minutes postdose
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Single arm study; no control data. No hypothesis testing done. Summaries provided using descriptive statistics. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Time to Reach Cmax (Tmax) [2] | ||||||||||||||||
End point description |
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. Here, n=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).
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End point type |
Primary
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End point timeframe |
Day 7, Up to 80 minutes postdose
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Single arm study; no control data. No hypothesis testing done. Summaries provided using descriptive statistics. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Time to last measurable concentration (Tlast) [3] | ||||||||||||||||
End point description |
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. Here, n=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).
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End point type |
Primary
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End point timeframe |
Day 7, Up to 80 minutes postdose
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Single arm study; no control data. No hypothesis testing done. Summaries provided using descriptive statistics. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Area under the analyte plasma concentration-time curve to the last quantifiable sampling time point [AUC(0-tlast)] [4] | ||||||||||||||
End point description |
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. Here, n=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).
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End point type |
Primary
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End point timeframe |
Day 7, Up to 80 minutes postdose
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Single arm study; no control data. No hypothesis testing done.Summaries provided using descriptive statistics. |
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Area Under the Analyte Plasma Concentration-time Curve Over the Dosing Interval (Inf)[AUC(0-∞)] [5] | ||||||||||||
End point description |
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. Here, n=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). 99999=standard deviation was not estimated.
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End point type |
Primary
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End point timeframe |
Day 7, Up to 80 minutes postdose
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Single arm study; no control data. No hypothesis testing done. Summaries provided using descriptive statistics. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Half-life (t½) [6] | ||||||||||||
End point description |
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. Here, n=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). 99999=standard deviation was not estimated.
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End point type |
Primary
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End point timeframe |
Day 7, Up to 80 minutes postdose
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| Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Single arm study; no control data. No hypothesis testing done. Summaries provided using descriptive statistics. |
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
Adverse events (AEs) were collected for the duration of the study (6 months). This analysis group includes all participants who received study drug.
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Adverse event reporting additional description |
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.
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Assessment type |
Systematic | ||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||
Dictionary version |
15.0
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Reporting groups
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Reporting group title |
Travoprost
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Reporting group description |
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 | ||||||||||||||||||||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No non-serious adverse events occurred above the reporting threshold. |
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
