A 3 Month, Multicenter, Double-Masked Safety and Efficacy Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 184
- 主要终点
- Mean Change From Baseline in IOP at Month 3
研究概览
简要总结
The purpose of this study is to evaluate the intraocular pressure (IOP)-lowering efficacy of Travoprost 0.004% POLYQUAD (PQ) ophthalmic solution compared to Timolol ophthalmic solution (0.5% or 0.25%) in pediatric glaucoma patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 pediatric glaucoma or ocular hypertension.
- •Qualifying mean IOP at the Eligibility Visit in at least one eye.
- •Written informed consent, including assent when applicable, MUST be obtained from the parent or legally authorized representative prior to any procedure specified in the protocol, including screening procedures.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Females of childbearing potential who are pregnant, intend to become pregnant during the study period, breast feeding, or not using any form of birth control measures.
- •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.
- •Severe ocular pathology (including severe dry eye) that, in the opinion of the Investigator, would preclude the administration of a topical prostaglandin analog or a topical beta-blocker.
- •Intraocular surgery in the study eye within 30 days prior to the Screening Visit.
- •Any abnormality preventing reliable applanation tonometry.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Travoprost
Travoprost 0.004% PQ ophthalmic solution, 1 drop administered in each eye in the evening with travoprost vehicle administered once daily in the morning for 3 months
干预措施: Travoprost 0.004% PQ ophthalmic solution (Drug)
Travoprost
Travoprost 0.004% PQ ophthalmic solution, 1 drop administered in each eye in the evening with travoprost vehicle administered once daily in the morning for 3 months
干预措施: Travoprost Vehicle (Drug)
Timolol
Timolol, 0.5% or 0.25% ophthalmic solution, 1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months
干预措施: Timolol, 0.5% or 0.25% ophthalmic solution (Drug)
结局指标
主要结局
Mean Change From Baseline in IOP at Month 3
时间窗: Baseline (Day 0), Month 3
IOP (fluid pressure inside the eye) was assessed using a calibrated tonometer and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye from each participant was chosen as the study eye and only the study eye was used for analysis.
次要结局
未报告次要终点