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 18, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to assess the safety and describe the steadystate plasma pharmacokinetic 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 analyte plasma concentration (Cmax) [ Time Frame: Day 7: predose, 0, 10, 20, 40, 80 minutes post-dose ] [ Designated as safety issue: No ]
  • Time to reach Cmax (Tmax) [ Time Frame: Day 7: predose, 0, 10, 20, 40, 80 minutes post-dose ] [ Designated as safety issue: No ]
  • Time to last measurable concentration (Tlast) [ Time Frame: Day 7: predose, 0, 10, 20, 40, 80 minutes post-dose ] [ Designated as safety issue: No ]
  • Area under the analyte plasma concentration-time curve to the last quantifiable sampling time point [AUC(0-last)] [ Time Frame: Day 7: predose, 0, 10, 20, 40, 80 minutes post-dose ] [ Designated as safety issue: No ]
  • Area under the analyte plasma concentration-time curve over the dosing interval (inf)[AUC(0-∞) [ Time Frame: Day 7: predose, 0, 10, 20, 40, 80 minutes post-dose ] [ Designated as safety issue: No ]
  • Half-life (t½) [ Time Frame: Day 7: predose, 0, 10, 20, 40, 80 minutes post-dose ] [ Designated as safety issue: No ]

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:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Less than 18 years of age at the time of screening.
  • 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.
  • 1 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.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658839

Locations
United States, Texas
Contact Alcon Call Center at 1-888-451-3937 for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
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
Last Updated: July 18, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 16, 2014