Back to resultsPharmacokinetic and Safety Study of Travoprost 0.004% in Pediatric Glaucoma Patients
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Travoprost ophthalmic solution, 0.004% (new formulation)
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring pediatric glaucoma, pediatric ocular hypertension, travoprost
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of glaucoma or ocular hypertension in at least 1 eye.
- Parent/legal guardian must provide informed consent, and children must agree to sign an approved assent form when applicable.
- Must agree to comply with the requirements of the study and must be accompanied by a parent/guardian.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Females of childbearing potential that are currently pregnant, have a positive result on a pregnancy test at the Screening Visit, intend to become pregnant during the study period, are breast feeding, or are not using birth control measures.
- One sighted eye or monocular, including patients who cannot be dosed in both eyes for any reason.
- History of chronic, recurrent or severe inflammatory eye disease.
- Ocular trauma requiring medical attention within the past 3 months prior to the Screening Visit.
- Ocular infection or ocular inflammation within the past 30 days prior to the Screening Visit.
- Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
- Other severe ocular pathology (including severe dry eye), that in the opinion of the Investigator, would preclude the administration of a topical prostaglandin analogue.
- Intraocular surgery within the past 30 days prior to the Screening Visit.
- Any abnormality preventing reliable tonometry.
- Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study.
- Hypersensitivity to prostaglandin analogues or to any component of the study medications in the opinion of the Investigator.
- Therapy with another investigational agent or device within 30 days prior to the Screening Visit.
- Body weight < 5kg.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Travoprost
Arm 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
Outcomes
Primary Outcome Measures
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 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 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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01658839
Brief Title
Pharmacokinetic and Safety Study of Travoprost 0.004% in Pediatric Glaucoma Patients
Official Title
An Open-Label, Pharmacokinetic and Safety Study of Travoprost Ophthalmic Solution, 0.004% in Pediatric Glaucoma or Ocular Hypertension Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
Keywords
pediatric glaucoma, pediatric ocular hypertension, travoprost
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Travoprost
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Travoprost ophthalmic solution, 0.004% (new formulation)
Intervention Description
Travoprost ophthalmic solution, 0.004%, new formulation
Primary Outcome Measure Information:
Title
Maximum Observed Travoprost Free Acid Plasma Concentration (Cmax)
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
Title
Time to Reach Cmax (Tmax)
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
Title
Time to Last Measurable Concentration (Tlast)
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
Title
Area Under the Analyte Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point [AUC(0-tlast)]
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
Title
Area Under the Analyte Plasma Concentration-time Curve Over the Dosing Interval (Inf)[AUC(0-∞)]
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
Title
Half-life (t½)
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of glaucoma or ocular hypertension in at least 1 eye.
Parent/legal guardian must provide informed consent, and children must agree to sign an approved assent form when applicable.
Must agree to comply with the requirements of the study and must be accompanied by a parent/guardian.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Females of childbearing potential that are currently pregnant, have a positive result on a pregnancy test at the Screening Visit, intend to become pregnant during the study period, are breast feeding, or are not using birth control measures.
One sighted eye or monocular, including patients who cannot be dosed in both eyes for any reason.
History of chronic, recurrent or severe inflammatory eye disease.
Ocular trauma requiring medical attention within the past 3 months prior to the Screening Visit.
Ocular infection or ocular inflammation within the past 30 days prior to the Screening Visit.
Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
Other severe ocular pathology (including severe dry eye), that in the opinion of the Investigator, would preclude the administration of a topical prostaglandin analogue.
Intraocular surgery within the past 30 days prior to the Screening Visit.
Any abnormality preventing reliable tonometry.
Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study.
Hypersensitivity to prostaglandin analogues or to any component of the study medications in the opinion of the Investigator.
Therapy with another investigational agent or device within 30 days prior to the Screening Visit.
Body weight < 5kg.
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Subha Venkataraman
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic and Safety Study of Travoprost 0.004% in Pediatric Glaucoma Patients
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