NCT00892762已完成3 期
Travoprost APS Versus Xalatan® in Patient Reported Outcomes and Ocular Surface Health
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 434
- 主要终点
- Mean NEI VFQ-25 composite score at the end of the treatment period (Day 90)
研究概览
简要总结
The purpose of this study is to understand differences in visual function-related patient-reported outcomes between a non-BAK medication (Travoprost APS) and a BAK-preserved medication (XALATAN®) in patients with open-angle glaucoma or ocular hypertension.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a clinical diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component), or ocular hypertension in at least 1 eye.
- •Must be willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study.
- •Must have had Intraocular Pressure (IOP) controlled with mono-therapy using XALATAN® for at least 1 continuous month prior to Visit
- •Women of childbearing potential must meet all of the following conditions at Visit 1:
- •They are not breast-feeding.
- •They have a negative urine pregnancy test at Visit
- •They agree to undertake a urine pregnancy test upon entering and exiting the study.
- •They are not planning to become pregnant during the course of the study.
- •They are currently using, and agree to use adequate birth control methods for the duration of the study.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Any abnormality preventing reliable applanation tonometry in the study eye(s).
- •Presence of any ocular pathology in either eye seen during the slit lamp or fundus exams, that in the opinion of the Investigator may preclude the safe administration of test article or safe participation in this study.
- •Dry eye or keratoconjunctivitis sicca (KCS) which has been, or is currently being, treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
- •Patients who have undergone keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface, including but not limited to LASIK and PRK, within 6 months prior to Visit
- •Patients who have undergone intraocular or extra-ocular surgery, in either eye, within 6 months prior to Visit
- •Any history of ocular infections or inflammatory ocular conditions within the past 3 months in either eye.
- •Use of any systemic medications on a chronic basis that have not been on a stable dosing regimen for at least 30 days prior to Visit
- •Use of ocular medications other than XALATAN® within 7 days of Visit
- •Use of corticosteroids within 30 days of Visit
- •Use of contact lenses within 30 days of Visit
- •Concomitant use of contact lenses is also excluded for the duration of the study.
- •History of intolerance or hypersensitivity to any component of the test articles.
- •Participation in an investigational drug or device study within 30 days of entering this study.
- •History or evidence of corneal transplant or transplant variant procedures.
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
Travoprost APS
Experimental
Travoprost APS 40 micrograms/ml eye drop solution, 1 drop in the study eye(s), once daily each evening, for 90 days
干预措施: Travoprost APS 40 micrograms/ml eye drop solution (Drug)
XALATAN
Active Comparator
Latanoprost 50 micrograms/ml eye drop solution, 1 drop in the study eye(s), once daily each evening, for 90 days
干预措施: Latanoprost 50 micrograms/ml eye drop solution (Drug)
结局指标
主要结局
Mean NEI VFQ-25 composite score at the end of the treatment period (Day 90)
时间窗: Day 90
次要结局
未报告次要终点
研究者
相似试验
已完成
不适用
Comparision of Visual Outcomes and Patient Satisfaction Between Two Diffractive Trifocal Intraocular LensesCataract SenileNCT04655274Akdeniz University30
终止
4 期
Effects of Anti-Glaucoma Medications on the Ocular SurfaceGlaucomaNCT01315574Massachusetts Eye and Ear Infirmary14
终止
3 期
DuoTrav APS Versus XALACOM® in Ocular Surface HealthOpen Angle GlaucomaOcular HypertensionNCT00912054Alcon Research240
已完成
4 期
Mechanism of Action of TRAVATAN 0.004% in Subjects With Glaucoma or Ocular HypertensionGlaucomaOcular HypertensionNCT00061503Alcon Research
已完成
不适用
Evaluation the TECNIS IOL in Both Eyes VS the ReZoom IOL in One and TECNIS IOL in the OppositeCataractNCT01253239Frank A. Bucci, Jr., M.D.175