Assessing the Efficacy and Tolerability of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-Free Fixed Combination), as Replacement Therapy in Patients Previously on Prior Prostaglandin Fixed Combination
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Change in intra-ocular pressure (IOP) at final visit from prior therapy (i.e., from baseline)
研究概览
简要总结
The purpose of this study is to assess efficacy and tolerability of changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-free) from prior Xalacom® or Ganfort® fixed combination pharmacotherapy in patients with open-angle glaucoma or ocular hypertension with uncontrolled intraocular pressure (IOP).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of ocular hypertension, open-angle glaucoma, or pigment dispersion glaucoma in both eyes.
- •On a stable IOP-lowering regimen of prostaglandin fixed combination (either Xalacom or Ganfort) within 4 weeks prior to the Screening Visit.
- •IOP between 19 and 35 mmHg at any time of day in at least 1 eye.
- •Best corrected visual acuity (BCVA) of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.
- •Willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Known medical history of allergy, hypersensitivity, or poor tolerance to any component of DuoTrav® deemed clinically significant in the opinion of the Principal Investigator.
- •Corneal dystrophies in either eye.
- •Risk of visual field or VA worsening as a consequence of participation in the study, in the investigator's best judgment.
- •Any disease or condition that would preclude the safe administration of a topical beta-blocker, present a special risk to the subject, or interfere with optimal participation in the study.
- •Women who are pregnant or lactating.
- •Participation in any other investigational study within 30 days prior to the Screening Visit.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
DuoTrav
Travoprost/Timolol Maleate BAK-Free Fixed Combination, 1 drop self-administered in treated eye(s) once a day for 12 weeks
干预措施: Travoprost/Timolol Maleate BAK-Free Fixed Combination (Drug)
结局指标
主要结局
Change in intra-ocular pressure (IOP) at final visit from prior therapy (i.e., from baseline)
时间窗: 12 weeks
Goldmann applanation tonometry will be performed at the baseline visit and the 12-week visit to record IOP. Change in IOP will be calculated. IOP will be measured in mmHg.
次要结局
- Percentage of patients who reach target IOP (≤18mmHg)(12 weeks)
- Change in Ocular Surface Disease Index (OSDI) score at final visit from baseline(12 weeks)
- Change in ocular hyperemia score at final visit from baseline(12 weeks)