Phase 1
N=25
Pharmacokinetic and Safety Study of Travoprost 0.004% in Pediatric Glaucoma Patients
Glaucoma · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01658839 ↗Enrolled (actual)
25
Serious AEs
4.0%
Results posted
Jul 2014
Primary outcome: Primary: Maximum Observed Travoprost Free Acid Plasma Concentration (Cmax) — 0.0256; 0.0471; 0.0258; 0.0109 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Travoprost ophthalmic solution, 0.004% (new formulation) (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Travoprost Free Acid Plasma Concentration (Cmax) |
0.0256; 0.0471; 0.0258; 0.0109 | — |
| PRIMARY Time to Reach Cmax (Tmax) |
0.25; 0.26; 0.17; 0.39 | — |
| PRIMARY Time to Last Measurable Concentration (Tlast) |
0.42; 0.34; 0.46; 0.39 | — |
| PRIMARY Area Under the Analyte Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point [AUC(0-tlast)] |
0.0116; 0.0101; 0.0123 | — |
| PRIMARY Area Under the Analyte Plasma Concentration-time Curve Over the Dosing Interval (Inf)[AUC(0-∞)] |
0.0389; 0.0389 | — |
| PRIMARY Half-life (t½) |
0.53; 0.53 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01658839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.