Examination of Ocular Surface Effects With Administration of TRAVATAN Z® and XALATAN®
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 236
- 主要终点
- Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break-Up Time (TFBUT)
研究概览
简要总结
The purpose of this study is to compare two ophthalmic solutions 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
- •18 years or older.
- •Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
- •Intraocular pressure (IOP) controlled with BAK (benzalkonium chloride) preserved IOP-lowering medication for 1 year, with last 6 months on XALATAN® monotherapy.
- •Best corrected visual acuity of -0.6 logMAR or better in each eye.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Treatment with BAK preserved artificial tears within 30 days of Visit
- •Known or suspected Sjogren's disease.
- •Uncontrolled IOP.
- •History or evidence of infectious or inflammatory ocular conditions.
- •Progressive retinal or optic nerve disease.
- •Ocular laser surgery within 3 months of Visit
- •Keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface within 1 year of Visit
- •Current use of punctal plugs or punctal cautery.
- •Use of systemic medications that has not been stable for 30 days prior to Visit
- •Use of contact lens within 30 days of Visit
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Travoprost
One drop self-administered in the study eye(s) once daily at night for 12 weeks
干预措施: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) (Drug)
Latanoprost
One drop self-administered in the study eye(s) once daily at night for 12 weeks
干预措施: Latanoprost ophthalmic solution 0.005% (XALATAN®) (Drug)
结局指标
主要结局
Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break-Up Time (TFBUT)
时间窗: Day 0, Day 84
Tear film break-up time was assessed by the same examiner both visits using the same slitlamp/settings. Examiner instilled fluorescein onto the patient's eye, after which the patient blinked several times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to time the occurrence of the first break in the fluorescein film. Three consecutive measurements were taken and averaged for actual TBUT. TBUT at Baseline (Day 0) was subtracted from TBUT at 12 weeks (Day 84) and reported as change. A higher number represents a lengthening in the tear film break up time.
次要结局
- Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score(Day 0, Day 84)