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

Phase 1

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: Travoprost ophthalmic solution, 0.004% (new formulation)

• Registration Number: NCT01658839
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2012-08-03
• Study First Submitted QC: 2012-08-06
• Study First Posted: 2012-08-07
• Study Start: 2013-01
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Results First Submitted: 2014-06-24
• Results First Submitted QC: 2014-06-24
• Results First Posted: 2014-07-21
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-04
• Last Update Posted: 2016-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Travoprost	Travoprost ophthalmic solution, 0.004% (new formulation)	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

Primary Outcome Measures

Name	Time	Method
Area Under the Analyte Plasma Concentration-time Curve Over the Dosing Interval (Inf)[AUC(0-∞)]	Day 7, Up to 80 minutes postdose	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.
Maximum Observed Travoprost Free Acid Plasma Concentration (Cmax)	Day 7, Up to 80 minutes postdose	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)	Day 7, Up to 80 minutes postdose	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.
Area Under the Analyte Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point [AUC(0-tlast)]	Day 7, Up to 80 minutes postdose	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.
Half-life (t½)	Day 7, Up to 80 minutes postdose	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 to Last Measurable Concentration (Tlast)	Day 7, Up to 80 minutes postdose	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.