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OpenTrials
Completed

NCT Number: NCT01658839

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

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Key information

Conditions

Glaucoma Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Abnormalities Eye Diseases Glaucoma, Open-Angle Hydrophthalmos Infant, Newborn, Diseases Ocular Hypertension

Age range

2 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Travoprost ophthalmic solution, 0.004% (new formulation)

Drug

Travoprost ophthalmic solution, 0.004%, new formulation

Primary outcomes

  1. Maximum Observed Travoprost Free Acid Plasma Concentration (Cmax)

    Time frame: 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.

  2. Time to Reach Cmax (Tmax)

    Time frame: 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.

  3. Time to Last Measurable Concentration (Tlast)

    Time frame: 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.

  4. Area Under the Analyte Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point [AUC(0-tlast)]

    Time frame: 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.

  5. Area Under the Analyte Plasma Concentration-time Curve Over the Dosing Interval (Inf)[AUC(0-∞)]

    Time frame: 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.

  6. Half-life (t½)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 7, 2012
Registry last updated
Apr 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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