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

Study Overview
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Brief Summary
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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.

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

Conditions
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Travoprost ophthalmic solution, 0.004% (new formulation)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Travoprost<br>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)<br>* Travoprost ophthalmic solution, 0.004%, new formulation<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric glaucoma, pediatric ocular hypertension, travoprost