跳至主要内容
临床试验/EUCTR2007-001046-41-GB
EUCTR2007-001046-41-GB进行中(未招募)不适用

Effectiveness of GANfort® in reducing intraocular pressure in patients presenting with significantly elevated intraocular pressure

ottingham University Hospital NHS Trust (Research & Development)0 个研究点开始时间: 2007年10月10日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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

  • 1.Newly diagnosed open angle glaucoma (OAG) or ocular hypertension(OHT) patients with IOPs ³ 25mmHg at presentation and on baseline assessment.
  • 2.OAG and OHT patients presently treated for their raised IOP and willing to undergo a washout period of no medication prior to starting GANfort®
  • 3.No contraindications to any of components of GANfort®
  • 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

  • 1.1.Unwilling to sign informed consent
  • 2.Patients in whom Beta blockers are contraindicated
  • 3.Patient with a history of severe cardiac disease or overt cardiac failure
  • 4.Sinus Bradycardia, second or third degree Atrioventricular blockPatient with severe asthma, bronchospasm or COAD
  • 5.Paediatric age group
  • 6.Known hypersensitivity to any of the drug ingredients
  • 7.Ocular condition that are of safety concern and that can interfere with the study results
  • 8.Patients with macular oedema
  • 9.Patients with neovascular glaucoma or angle closure glaucoma
  • 10.Closed or narrow anterior chamber angles or history of acute angle closure.
  • 11.Ocular surgery or argon laser trabeculoplasty within the last three months.
  • 12.Ocular inflammation/infection occurring within three months prior to pre-trial visit.
  • 13.Concominant topical ocular medication that can interfere with study medication
  • 14.Other abnormal condition or symptom preventing the patient from entering the trial, according to the Investigator's judgement.
  • 15.Refractive surgery patients at any time
  • 16.Women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing.
  • 17.Inability to adhere to treatment/visit plan.
  • 18.Have participated in any other clinical trial (i.e., requiring informed consent) within one to three month prior to pre-trial visit (depending on ethics committee decisions).

研究者

发起方
ottingham University Hospital NHS Trust (Research & Development)

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