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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01658839
First received: August 3, 2012
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Glaucoma
Ocular Hypertension
Drug: Travoprost ophthalmic solution, 0.004% (new formulation)
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Pharmacokinetic and Safety Study of Travoprost Ophthalmic Solution, 0.004% in Pediatric Glaucoma or Ocular Hypertension Patients

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Maximum Observed Travoprost Free Acid Plasma Concentration (Cmax) [ Time Frame: Day 7, Up to 80 minutes postdose ] [ Designated as safety issue: No ]
    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) [ Time Frame: Day 7, Up to 80 minutes postdose ] [ Designated as safety issue: No ]
    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) [ Time Frame: Day 7, Up to 80 minutes postdose ] [ Designated as safety issue: No ]
    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)] [ Time Frame: Day 7, Up to 80 minutes postdose ] [ Designated as safety issue: No ]
    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-∞)] [ Time Frame: Day 7, Up to 80 minutes postdose ] [ Designated as safety issue: No ]
    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) [ Time Frame: Day 7, Up to 80 minutes postdose ] [ Designated as safety issue: No ]
    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.


Enrollment: 25
Study Start Date: January 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658839

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Subha Venkataraman Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01658839     History of Changes
Other Study ID Numbers: C-12-009, 2012-001640-22
Study First Received: August 3, 2012
Results First Received: June 24, 2014
Last Updated: July 28, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Saudi Arabia: Ethics Committee
France: Institutional Ethical Committee
Spain: Ethics Committee

Keywords provided by Alcon Research:
pediatric glaucoma
pediatric ocular hypertension
travoprost

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Cloprostenol
Ophthalmic Solutions
Pharmaceutical Solutions
Travoprost
Antihypertensive Agents
Cardiovascular Agents
Contraceptive Agents
Contraceptive Agents, Female
Luteolytic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014