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
- 231
- 主要终点
- Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break Up Time (TBUT)
研究概览
简要总结
The purpose of this randomized, double-masked, parallel-group, multicenter study is to evaluate ocular surface effects after the administration of travoprost with SofZia® preservative system or Xalatan once daily for 12 weeks.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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 of age or older.
- •Diagnosis of primary open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion) or ocular hypertension in at least one eye (study eye).
- •Use of BAK (benzalkonium chloride) containing intraocular pressure (IOP) lowering medication for a minimum of one year, including latanoprost (Xalatan®) monotherapy for at least 6 months prior to Visit
- •IOP controllable and stable on the study medication alone (both eyes).
- •Believed to have ocular surface disease (OSD).
- •Tear Break-up Time (TBUT) of ≤ 6 seconds in the study eye.
- •Willing and able to discontinue the use of any topical ocular medication other than the study medication or BAK free artificial tears for the duration of the study.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Current use or use within the last 3 months of cyclosporine ophthalmic emulsion 0.05% (Restasis®), topical ocular steroids, or topical ocular non-steroidal anti-inflammatory drugs.
- •Current use of punctual plugs.
- •Women of childbearing potential not using reliable means of birth control.
- •Women who are pregnant or lactating.
- •Suspected or diagnosed with Sjogrens's syndrome.
- •Current use of any brand of artificial tears containing BAK.
- •Use of any systemic medications on a chronic basis not on a stable dosing regimen for at least 30 days prior to Visit 1, or an anticipated change in dosing regimen of medications during the course of the study.
- •Intraocular conventional surgery or laser surgery in study eyes less than six months prior to Visit
- •Current use of contact lenses within 30 days of Visit
- •Participation in any other investigational study within 30 days prior to 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 (TBUT)
时间窗: 12 weeks (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(12 weeks (Day 84))