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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01658839
• Other study ID #: C-12-009
• Secondary ID: 2012-001640-22
• Status: Completed
• Phase: Phase 1
• First received: August 3, 2012
• Last updated: June 28, 2015
• Start date: January 2013
• Est. completion date: July 2013

Study information

• Verified date: July 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardSaudi Arabia: Ethics CommitteeFrance: Institutional Ethical CommitteeSpain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 17 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• Travoprost ophthalmic solution, 0.004% (new formulation)
Travoprost ophthalmic solution, 0.004%, new formulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Area Under the Analyte Plasma Concentration-time Curve Over the Dosing Interval (Inf)[AUC(0-8)]	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(0-8) was calculated for each participant with at least 3 quantifiable time points.	Day 7, Up to 80 minutes postdose	No
Primary	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	No