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临床试验/NCT01175902
NCT01175902已完成不适用

To Prove the Non-inferiority of Cosopt Compared to Xalatan in the Aspects of Intraocular Pressure and Ocular Perfusion Pressure in Subjects With Normal Tension Glaucoma

The Catholic University of Korea1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Intraocular Pressure (IOP), Period 1

研究概览

简要总结

To prove the non-inferiority of the fixed timolol-dorzolamide combination (Cosopt) compared to 0.005% latanoprost (Xalatan) in the aspects of intraocular pressure (IOP) and ocular perfusion pressure (OPP) in subjects with normal tension glaucoma (NTG)

Clinical hypotheses. Primary hypothesis

  • Cosopt group is non-inferior to Xalatan group in diurnal IOP reduction.

Secondary hypothesis

  • Cosopt group is non-inferior to Xalatan group in diurnal diastolic and systolic OPP.

详细描述

Cosopt (dorzolamide/timolol fixed combination) has well known effect for IOP reduction in POAG and OHT.3-5 However, there is no study about the effect and safety of Cosopt in NTG, Cosopt is not used the first line drug in the management of NTG.

In Korea, the prevalence of NTG is higher than western countries, the majority (about 80-90%) of open angle glaucoma patients have an IOP of 21 mmHg or less, so the study of NTG is important and searching of effective drug for the treatment of NTG is necessary.

In this study, we would prove the non-inferiority of Cosopt compared to Xalatan,6 which is used as a first line drug in the management of NTG, in the aspects of IOP and OPP including diastolic OPP (DOPP).

A prospective, interventional, randomized, crossover, single masked, single center study. Forty-four NTG patients were randomly allocated to one of two groups. Patients in group A were treated with Cosopt, lubricant, and Xalatan for 4 weeks each, whereas patients in group B were treated with Xalatan, lubricant, and Cosopt for 4 weeks each.

Recruit NTG patients, who are not treated with the glaucoma medication recent 2 months. If treated, after washout period of 4 weeks, the patients can be included in the study. Baseline IOP, systolic and diastolic BP will be measured. (Day 1) After 4 weeks of treatment of Cosopt or Xalatan, all participants will be checked diurnal IOP, systolic and diastolic BP. IOP was measured by Goldmann applanation tonometry (mean of three consecutive readings) with the patient in a sitting position at the slit lamp. Every IOP will be measured by one masked glaucoma specialist who is unaware of the treatment assignments. After the IOP measurements, after a 5-minite rest, pulse rate and BP (systolic and diastolic) of radial artery were measured in the sitting position using a standard automated blood pressure cuff. During the period, all measuring instruments keep to be calibrated by the manufacturer's instruction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Arm 1

Active Comparator

Latanoprost first, then Dorzolamide/Timolol Patients first on Latanoprost eyedrops once a day, then on Dorzolamide/Timolol twice a day

干预措施: dorzolamide/timolol (Drug)

Arm 1

Active Comparator

Latanoprost first, then Dorzolamide/Timolol Patients first on Latanoprost eyedrops once a day, then on Dorzolamide/Timolol twice a day

干预措施: latanoprost (Drug)

Arm 2

Active Comparator

Dorzolamide/Timolol first, then Latanoprost Patients first on Dorzolamide/Timolol eyedrops twice a day, then on Latanoprost eyedrops once a day

干预措施: dorzolamide/timolol (Drug)

Arm 2

Active Comparator

Dorzolamide/Timolol first, then Latanoprost Patients first on Dorzolamide/Timolol eyedrops twice a day, then on Latanoprost eyedrops once a day

干预措施: latanoprost (Drug)

结局指标

主要结局

Intraocular Pressure (IOP), Period 1

时间窗: 4 weeks

IOP (mean IOP) after 4 weeks of treatment

Intraocular Pressure (IOP), Period 2

时间窗: 12 weeks

IOP (mean IOP) after treaemt from week 8 to week 12

Blood Pressure (BP), Period 1

时间窗: 4 weeks

systolic and diastolic BP at 4 weeks after use of eyedrops

Blood Pressure (BP), Period 2

时间窗: 12 weeks

systolic and diastolic BP measured after treaemt from week 8 to week 12

次要结局

  • Ocular Perfusion Pressure (OPP), Period 1(4 weeks)
  • OPP, Period 2(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chan Kee Park

Seoul St. Mary's Hospital

The Catholic University of Korea

研究点 (1)

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