NCT00906594已完成4 期
Additive Intra-ocular Pressure Reduction Effect of Fixed Combination of Maleate Timolol 0.5%/Dorzolamide 2% on Monotherapy With Latanoprost in Patients With Elevated Intra-ocular Pressure: a Prospective, Four-week, Open-label, Randomized, Controlled Clinical Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- additional IOP reduction obtained with cosopt in addition to xalatan
研究概览
简要总结
The purpose of this study is to evaluate the additive effect of dorzolamide/timolol fixed combination in patients undergoing monotherapy with latanoprost.
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
- 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
- •All patients were at least 18 years old, with unilateral or bilateral open-angle glaucoma (defined as IOP > 21 mmHg, mean of three consecutive measurements, at any time during the day, at the moment of glaucoma diagnosis) or ocular hypertension (IOP> 25 mmHg, mean of three consecutive measurements, at anytime during the day, at the moment of diagnosis). Glaucoma was defined as a reproducible glaucomatous visual field defect based on GHT outside normal limits and/or PSD lower than 0,5% or glaucomatous changes of the optic disc associated to elevated IOP. A visual acuity (ETDRS) of 20/80 or better was required for randomization.
排除标准
- •Included woman of childbearing potential, pregnancy, systemic contra-indication to beta-blocker therapy, argon laser trabeculoplasty three months before screening visit, any history of filtering surgery, ocular surgery or uveitis three months before screening visit, hypersensitivity to any compound of the study drugs, concomitant use of any experimental drug, any condition in which treatment with beta-blocker is contraindicated or any other abnormal and/or ocular condition or symptom that would prevent study participation, according to the judgment of the investigator. The use of systemic beta-blocker, if needed, was allowed and not considered an exclusion criterion. Latanoprost non-responders defined as lower than 15% IOP reduction after run-in period with latanoprost monotherapy were excluded from the study.
研究组 & 干预措施
Latanoprost
Active Comparator
Latanoprost mono therapy
干预措施: latanoprost (Drug)
Latanoprost + Fixed combination
Experimental
Latnoprost + Fixed combination
干预措施: latanoprost (Drug)
结局指标
主要结局
additional IOP reduction obtained with cosopt in addition to xalatan
时间窗: 4 week
次要结局
未报告次要终点
研究者
Marcelo Hatanaka
Head, Glaucoma Service
University of Sao Paulo
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Lumigan Versus CosoptOpen-Angle GlaucomaNCT00273455Pharmaceutical Research Network34
已完成
不适用
Intraocular Pressure, Blood Pressure, Ocular Perfusion and Blood Flow Fluctuations in Glaucoma PatientsOpen Angle GlaucomaNCT01304264Lithuanian University of Health Sciences35
已完成
4 期
Impact of Timolol/Dorzolamide Therapy on Autoregulation in Glaucoma PatientsOpen Angle GlaucomaNCT02053298Universitaire Ziekenhuizen KU Leuven30
已完成
4 期
SIMBRINZA® Suspension BID as an Adjunctive to Prostaglandin Analogue (PGA)Ocular HypertensionOpen-Angle GlaucomaNCT02419508Alcon Research290
已完成
2 期
COSOPT (Timolol/Dorzolamide Combination) Normal Tension Glaucoma Study (MK0507A-161)(COMPLETED)GlaucomaNCT00832377Merck Sharp & Dohme LLC37