EUCTR2007-004023-38-IT进行中(未招募)不适用
Prospective, multicentric, double-masked clinical study to compare the efficacy and safety of Ganfort and Duotrav in primary open angle and pseudoexfoliative glaucoma patients previously treated with Xalacom - ND
IRCCS- FONDAZIONE G.B. BIETTI PER LO STUDIO E LA RICERCA IN OFTALMOLOGIA-ONLUS0 个研究点目标入组 124 人开始时间: 2007年11月29日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 124
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The patient is suffering from POAG or PEX (If the patient has glaucoma and high IOP in both eyes, both eyes will be treated but the worst eye chose for the statistical analysis). Glaucoma definition is based on the European Glaucoma Society Guidelines. The patient is on either a non-fixed combination of Xalatan and Timolol for at least 3 months or on Xalacom for at least 6 month The patient has an IOP<21 mm Hg at the 8am time point.. The patient has not reached the target IOP as set by the treating physician
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Not at least 18 years old Beta blockers are contraindicated Closed/barely open anterior chamber angles or history of acute angle closure. Ocular surgery or argon laser trabeculoplasty within the last three months. Ocular inflammation/infection occurring within three months prior to pre-trial visit. Concominant topical ocular medication that can interfere with study medication Hypersensitivity to benzalkonium chloride or to any other component of the trial drug solutions. Women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing.
研究者
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Prospective, multicentric, double-masked clinical study to compare the efficacy and safety of Ganfort and Duotrav in primary open angle and pseudoexfoliative glaucoma patients previously treated with XalacomEUCTR2007-004023-38-DEGB Bietti Eye Foundation - IRCCS124
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