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

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ClinicalTrials.gov Identifier: NCT01658839
Recruitment Status : Completed
First Posted : August 7, 2012
Results First Posted : July 21, 2014
Last Update Posted : April 1, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Travoprost

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658839


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Subha Venkataraman Alcon Research
More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01658839    
Other Study ID Numbers: C-12-009
2012-001640-22 ( EudraCT Number )
First Posted: August 7, 2012    Key Record Dates
Results First Posted: July 21, 2014
Last Update Posted: April 1, 2016
Last Verified: March 2016
Keywords provided by Alcon Research:
pediatric glaucoma
pediatric ocular hypertension
travoprost
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
 Eye Diseases
Travoprost
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents