EUCTR2013-003490-10-GB进行中（未招募）1 期
Intraocular Pressure And Tolerability Study of Preservative Free Bimatoprost 0.03% Unit Dose (BUDPF) or preservative free Latanoprost 0.005% Unit Dose (LUDPF) (Monopost)in patients with Ocular hypertension or Glaucoma: A Randomised, single masked, 3 month cross-over, Investigator led, European multicentre Trial (SPORT). - Intraocular Pressure And Tolerability Study - SPORT
AIBILI (EVICR.net)0 个研究点目标入组 67 人开始时间: 2013年11月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 67
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
- •A patient suffering from ocular hypertension, XFG or POAG that has been on a preserved prostaglandin monotherapy for at least 6 weeks and needs treatment in both eyes
- •? At pre-screening and screening visit (09:00 ? 1 hr) the IOP is less than or equal to 21 mm Hg in both eyes.
- •? Patient is aged between 40-84 at the time of consent
- •? Patient is able and willing to participate in the study for the whole duration of the follow up and is willing to sign the consent form
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 37
排除标准
- •Unwilling to sign informed consent;
- •? aged under 40 and after 84th birthday at the time of consent
- •? Ocular condition that are of safety concern and that can interfere with the study results;
- •? Visual field defects with an MD value above -12dB with Humphey or above +12dB with Octopus on either eye;
- •? Contact lens wearer;
- •? Closed/barely open anterior chamber angles or history of acute angle closure on either eye as assessed by gonioscopy;
- •? Ocular surgery (other than glaucoma surgery) or argon laser trabeculoplasty within the past three months on either eye;
- •? Glaucoma surgery within the past 6 months on either eye;
- •? Ocular inflammation/infection occurring within three months prior to pre-trial visit on either eye;
- •? Patients with pigmentary glaucoma on either eye;
- •? Patients with Neovascular glaucoma on either eye;
- •? Concomitant topical ocular medication that can interfere with study medication on either eye;
- •? Known hypersensitivity to any component of the trial drug solutions;
- •? Other abnormal condition or symptom preventing the patient from entering the trial, according to the Investigator's judgement;
- •? Refractive surgery patients at any time;
- •? Women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing;
- •? Inability to adhere to treatment/visit plan;
- •? Have participated in any other clinical trial (i.e., requiring informed consent) involving an investigational drug within one month prior to pre-trial visit.
研究者
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