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临床试验/NCT00347126
NCT00347126已完成不适用

Efficacy and Safety of a Systematic Switch From Latanoprost to Travoprost in Patients With Glaucoma

Singapore National Eye Centre1 个研究点 分布在 1 个国家目标入组 372 人开始时间: 2006年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
372
试验地点
1

研究概览

简要总结

Prostaglandin analogs are a leading class of glaucoma drugs with a proven safety and efficacy for controlling IOP. They include latanoprost, bimatoprost, travoprost and unoprostone. Recently, the Singapore National Eye Center (SNEC) awarded a tender for prostaglandin analogues to Alcon, the manufacturer of travoprost. Since then, all subsidized patients previously treated with latanoprost were systematically switched to travoprost and this process will continue for the rest of this year. In this study, we propose to prospectively study the efficacy and safety of switching from latanoprost to travoprost in a large series of glaucoma patients at SNEC. A total of 372 consecutive patients being switched from latanoprost to travoprost will be followed up for 12 weeks following the switch. In addition to intraocular pressure, the safety and tolerability (with particular emphasis on hyperemia) of travoprost will be examined.

详细描述

Aims:

  1. To assess the feasibility of switching a large group of patients on treatment with latanoprost to travoprost.
  2. To assess the efficacy and safety of travoprost compared to latanoprost after the switch.

Intraocular pressure (IOP) is currently the only proven modifiable risk factor in the management of glaucoma.1 Either medical or surgical management can achieve the control of IOP. Prostaglandin analogs are the newer class of drugs among the various topical ocular hypotensive medications, with a proven safety and efficacy for controlling IOP.2 Their potency and once a day dosing and lower incidence of systemic side effects have made them popular for use as monotherapeutic and first-line agents. They include latanoprost, bimatoprost, travoprost and unoprostone. All of them have a similar molecular structure and they work by increasing the aqueous drainage via trabecular meshwork and the uveoscleral pathway.3 It has been shown that the efficacy of latanoprost, bimatoprost and travoprost in reducing IOP in ocular hypertension and primary open angle glaucoma is comparable.4 Conjunctival hyperemia is one of the most common ocular side effects. There has been a reported higher incidence of hyperemia with bimatoprost and travoprost as compared to latanoprost.4 However, this hyperemia is usually benign and usually abates as the drug is used long term. The incidence of discontinuation of therapy due to hyperemia is very low and not different among the various prostaglandins.5 Among the prostaglandin analogues, latanoprost has been the market leader in Singapore for the past few years. However, the Singapore National Eye Center (SNEC) pharmacy recently accepted tenders from various drug companies for prostaglandin analogs. Alcon, the manufacturer of travoprost was awarded the tender. Since then, all subsidized patients previously treated with latanoprost were systematically switched to travoprost and this process will continue for the rest of this year. The switch is a systematic switch and is not based on intolerance or poor response to latanoprost.

To date, there has been a single report regarding the feasibility and efficacy of a mass switch from latanoprost to bimatoprost.5 The study reported a high switch rate and good IOP control with minimal switch back. However, similar data on switching from latanoprost to travoprost is lacking. In this study, we propose to prospectively study the efficacy and safety of switching from latanoprost to travoprost in a large series of glaucoma patients at SNEC. A total of 372 consecutive patients being switched from latanoprost to travoprost will be followed up for 12 weeks following the switch. In addition to IOP, safety and tolerability (with particular emphasis on hyperemia) of travoprost will be examined.

References:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients on treatment with latanoprost for at least 12 weeks; patients who are on additional beta-blockers topically will also be eligible.
  • Written informed consent. -

排除标准

  • Patients on 3 or more topical medications.
  • Recorded history of intolerance to travoprost.
  • Recorded history of inefficacy of travoprost in controlling IOP.
  • Patients on any additional topical medication other than beta-blockers.
  • History of non-compliance.
  • Involvement in any other concomitant study. -

研究者

申办方类型
Other Gov

研究点 (1)

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