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

An Open-Label, Pharmacokinetic and Safety Study of Travoprost Ophthalmic Solution, 0.004% in Pediatric Glaucoma or Ocular Hypertension Patients

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma
• Intervention / Treatment: Drug: Travoprost ophthalmic solution, 0.004% (new formulation)

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Travoprost ophthalmic solution, 0.004% (new formulation); Travoprost ophthalmic solution, 0.004%, new formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Day 7, Up to 80 minutes postdose

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Subha Venkataraman, Alcon Research

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: August 3, 2012
• First Submitted That Met QC Criteria: August 6, 2012
• First Posted (Estimate): August 7, 2012

Study Record Updates

• Last Update Posted (Estimate): April 1, 2016
• Last Update Submitted That Met QC Criteria: March 4, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: pediatric glaucoma; pediatric ocular hypertension; travoprost
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Ocular Hypertension; Hypertension; Antihypertensive Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Travoprost
• Other Study ID Numbers: C-12-009; 2012-001640-22 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No