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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01658839
Recruitment Status : Completed
First Posted : August 7, 2012
Results First Posted : July 21, 2014
Last Update Posted : April 1, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Glaucoma
Ocular Hypertension
Intervention Drug: Travoprost ophthalmic solution, 0.004% (new formulation)
Enrollment 25
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.
Pre-assignment Details Twenty-five participants were enrolled and completed the study. This reporting group includes all enrolled participants (25).
Arm/Group Title Travoprost
Hide Arm/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
Period Title: Overall Study
Started 25
Completed 25
Not Completed 0
Arm/Group Title Travoprost
Hide Arm/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
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
This analysis population includes all enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
9.9  (5.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
12
  48.0%
Male
13
  52.0%
1.Primary Outcome
Title Maximum Observed Travoprost Free Acid Plasma Concentration (Cmax)
Hide 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.
Time Frame Day 7, Up to 80 minutes postdose
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Travoprost
Hide Arm/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
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: ng/mL
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)
2.Primary Outcome
Title Time to Reach Cmax (Tmax)
Hide 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.
Time Frame Day 7, Up to 80 minutes postdose
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Travoprost
Hide Arm/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
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: hours
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)
3.Primary Outcome
Title Time to Last Measurable Concentration (Tlast)
Hide 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.
Time Frame Day 7, Up to 80 minutes postdose
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Travoprost
Hide Arm/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
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: hours
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)
4.Primary Outcome
Title Area Under the Analyte Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point [AUC(0-tlast)]
Hide 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.
Time Frame Day 7, Up to 80 minutes postdose
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Travoprost
Hide Arm/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
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
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)
5.Primary Outcome
Title Area Under the Analyte Plasma Concentration-time Curve Over the Dosing Interval (Inf)[AUC(0-∞)]
Hide 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.
Time Frame Day 7, Up to 80 minutes postdose
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Travoprost
Hide Arm/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
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
Overall (n=1) 0.0389 [1]   (NA)
3 to <12 years (n=1) 0.0389 [1]   (NA)
[1]
Standard deviation was not estimated
6.Primary Outcome
Title Half-life (t½)
Hide 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.
Time Frame Day 7, Up to 80 minutes postdose
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Travoprost
Hide Arm/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
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: hours
Overall (n=1) 0.53 [1]   (NA)
3 to <12 years (n=1) 0.53 [1]   (NA)
[1]
Standard deviation was not estimated
Time Frame Adverse events (AEs) were collected for the duration of the study (6 months). This analysis group includes all participants who received study drug.
Adverse Event Reporting 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.
 
Arm/Group Title Travoprost
Hide Arm/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
All-Cause Mortality
Travoprost
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Travoprost
Affected / at Risk (%)
Total   1/25 (4.00%) 
Surgical and medical procedures   
Trabeculectomy  1  1/25 (4.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Travoprost
Affected / at Risk (%)
Total   0/25 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Theresa Landry, Project Head, Clinical Trial Management
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01658839    
Other Study ID Numbers: C-12-009
2012-001640-22 ( EudraCT Number )
First Submitted: August 3, 2012
First Posted: August 7, 2012
Results First Submitted: June 24, 2014
Results First Posted: July 21, 2014
Last Update Posted: April 1, 2016