An Open-Label, Pharmacokinetic and Safety Study of Travoprost Ophthalmic Solution, 0.004% in Pediatric Glaucoma or Ocular Hypertension Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Area Under the Analyte Plasma Concentration-time Curve Over the Dosing Interval (Inf)[AUC(0-∞)]
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Travoprost ophthalmic solution, 0.004% (new formulation) (Drug)
结局指标
主要结局
Area Under the Analyte Plasma Concentration-time Curve Over the Dosing Interval (Inf)[AUC(0-∞)]
时间窗: 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.
Maximum Observed Travoprost Free Acid Plasma Concentration (Cmax)
时间窗: 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.
Time to Reach Cmax (Tmax)
时间窗: 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.
Area Under the Analyte Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point [AUC(0-tlast)]
时间窗: 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.
Half-life (t½)
时间窗: 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.
Time to Last Measurable Concentration (Tlast)
时间窗: 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.
次要结局
未报告次要终点