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

NCT01658839 | Completed Phase 1 Results

• 2 other identifiers: C-12-0092012-001640-22
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glaucoma; Ocular Hypertension

Keywords

pediatric glaucoma; pediatric ocular hypertension; travoprost

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

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

  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.

  Day 7, Up to 80 minutes postdose

• 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

Study Arms (1)

Travoprost

EXPERIMENTAL

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)

Interventions

Travoprost ophthalmic solution, 0.004% (new formulation) DRUG

Travoprost ophthalmic solution, 0.004%, new formulation

Travoprost

Eligibility Criteria

• Age: 2 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension; Hydrophthalmos

Condition Hierarchy (Ancestors)

Eye Diseases; Eye Abnormalities; Glaucoma, Open-Angle; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Results Point of Contact

• Title: Theresa Landry, Project Head, Clinical Trial Management
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Subha Venkataraman

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2012
• First Posted: August 7, 2012
• Study Start: January 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: April 1, 2016
• Results First Posted: July 21, 2014

Record last verified: 2016-03