Clinical trial NCT01658839: Pharmacokinetic and Safety Study of Travoprost 0.004% in Pediatric Glaucoma Patients
Official title: An Open-Label, Pharmacokinetic and Safety Study of Travoprost Ophthalmic Solution, 0.004% in Pediatric Glaucoma or Ocular Hypertension Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glaucoma
Ocular Hypertension
Keywords: pediatric glaucoma
pediatric ocular hypertension
travoprost
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-08-07
Enrollment: 25
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Maximum Observed Travoprost Free Acid Plasma Concentration (Cmax)
timeFrame: Day 7, Up to 80 minutes postdose
measure: Time to Reach Cmax (Tmax)
timeFrame: Day 7, Up to 80 minutes postdose
measure: Time to Last Measurable Concentration (Tlast)
timeFrame: Day 7, Up to 80 minutes postdose
measure: Area Under the Analyte Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point [AUC(0-tlast)]
timeFrame: Day 7, Up to 80 minutes postdose
measure: Area Under the Analyte Plasma Concentration-time Curve Over the Dosing Interval (Inf)[AUC(0-∞)]
timeFrame: Day 7, Up to 80 minutes postdose
measure: Half-life (t½)
timeFrame: Day 7, Up to 80 minutes postdose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Subha Venkataraman
role: STUDY_DIRECTOR
References: