EUCTR2005-004766-16-IT进行中（未招募）不适用
Comparison of safety and efficacy of Brinzolamide/Timolol fixed combination vs COSOPT in patients with open-angle glaucoma or ocular hypertension - Brinzolamide/Timolol fixed combination vs COSOPT
ALCON ITALIA0 个研究点目标入组 420 人开始时间: 2006年12月21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
- 420
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
- •-written informed consent, availability to satisfy the requirements of the informed consent - Patients, 18 years of age or older, diagnosed with open-angle glaucoma with or without pseudoexfoliation or pigment dispersion component or ocular hypertension who are currently on an IOP-lowering medication and, in the opinion of the investigator, would benefit from a combination therapy. -Patients must meet the following IOP entry criteria in at least one eye For each qualifying eye, the mean IOP must be 24 to 36 mmHg at 8 00 AM at both Eligibility Visits 1 and 2. For each qualifying eye, the mean IOP must be 21 to 36 mmHg at 10 00 AM at both Eligibility Visits 1 and 2. The mean IOP in either eye at any time point during Eligibility Visits 1 and 2 must not be greater than 36 mmHg. The same eye s must qualify at both Eligibility Visits 1 and 2. -Patients who wear contact lenses will be allowed to participate in the study provided that the contact lenses are removed before instillation of study medication, and that the patient waits a minimum of 15 minutes following drug instillation before re-inserting the lenses. Patients who wear contact lenses will be instructed to wear or bring their glasses with them on study visit days. - Patients using nonprescription and/or prescription topical ophthalmic and/or systemic non-IOP lowering medications except for those in the Exclusion Criteria may be included in the study.
- •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
- •- Females of childbearing potential are excluded if they meet any one of the following conditions They are currently pregnant or, They have a positive result on the urine pregnancy test at the Screening Visit or,they intend to become pregnant during the study period or,they are breast-feeding or,they are not using highly effective birth control measures. Patient who are chilbearing potential must consent to a urine pregnancy test at screening visit, at month 6 visit and at exit visit. - Patients with any form of glaucoma other than open-angle glaucoma with or without a pigment dispersion or pseudoexfoliation component or ocular hypertension. - Patients who are currently on therapy or were on therapy with another investigational agent within 30 days prior to the Screening Visit. - History of chronic, recurrent or current severe inflammatory eye disease in either eye. - History of ocular trauma within the past six 6 months in either eye. - History of or current ocular infection or ocular inflammation within the past three 3 months in either eye. History of or current clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye. - History of or current other ocular pathology including severe dry eye , in either eye, that would preclude the safe administration of a sulfonamide analogue. - History of severe or serious hypersensitivity to timolol maleate, topical or oral carbonic anhydrase inhibitors, sulfonamide derivatives, or to any components of the study medications - Intraocular surgery within the past 6 months as determined by patient history and/or examination in either eye. - Ocular laser surgery within the past 3 months as determined by patient history and/or examination in either eye. -Any abnormality preventing reliable applanation tonometry of either eye. -Patients with best-corrected visual acuity worse than 0.60 logMAR score in either eye. - Patients with angle grade less than Grade 2 in either eye, as measured by gonioscopy extreme narrow angle with complete or partial closure The cup/disc ratio is measured on both the vertical and horizontal axis. Patients are excluded if the cup/disc ratio is greater than 0.80 in either eye on the horizontal or vertical measurement. - Patients with severe central visual field loss in either eye. Severe central visual field loss is defined as a sensitivity of less than or equal to 10 dB in at least 2 of the 4 visual field test points closest to the point of fixation. - Patients who cannot safely discontinue use of all ocular IOP-lowering medication s for a minimum period of 5 days 1 day to twenty-eight 28 days 1 day prior to Eligibility 1 Visit. - Use of any additional topical or systemic ocular hypotensive medication during the study. - Recent within 4 weeks of the Eligibility 1 Visit use of high-dose 1 gram daily salicylate therapy. - History of spontaneous or current hypoglycemia or uncontrolled diabetes. -History of or current severe, unstable or uncontrolled cardiovascular, hepatic or renal disease that would preclude the safe administration of a topical beta-blocker. - History of or current bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker. - Patients who cannot safely discontinue all glucocorticoid medications administered by any route. - Patients must have washed ou
研究者
相似试验
进行中（未招募）
不适用
Comparison of Safety and Efficacy of Brinzolamide/Timolol Fixed Combination vs COSOPT in Patients with Open-Angle Glaucoma or Ocular Hypertension - Brinzolamide/Timolol Fixed Combination vs COSOPTEUCTR2005-004766-16-BEAlcon Research, Ltd.420
进行中（未招募）
不适用
Comparison of Safety and Efficacy of Brinzolamide/Timolol Fixed Combination vs COSOPT in Patients with Open-Angle Glaucoma or Ocular Hypertension - Brinzolamide/Timolol Fixed Combination vs COSOPTOpen Angle Glaucoma or Ocular HypertensionICD: H40.1/H40.0EUCTR2005-004766-16-SEAlcon Research, Ltd.420
进行中（未招募）
不适用
Comparison of Safety and Efficacy of Brinzolamide/Timolol Fixed Combination vs COSOPT in Patients with Open-Angle Glaucoma or Ocular Hypertension. - Brinzolamide/Timolol Fixed Combination vs COSOPTOpen-Angle Glaucoma or Ocular HypertensionEUCTR2005-004766-16-LTAlcon Research, Ltd.420
进行中（未招募）
不适用
Comparison of Safety and Efficacy of Brinzolamide/Timolol Fixed Combination vs COSOPT® in Patients with Open-Angle Glaucoma or Ocular Hypertension. - Brinzolamide/Timolol Fixed Combination vs COSOPTOpen –Angle Glaucoma or Ocular HypertensionEUCTR2005-004766-16-LVAlcon Research, Ltd.420
进行中（未招募）
1 期
Comparison of Safety and Efficacy of Brinzolamide/Timolol Fixed Combination vs COSOPT in Patients with Open-Angle Glaucoma or Ocular Hypertension - Brinzolamide/Timolol Fixed Combination vs COSOPTEUCTR2005-004766-16-GBAlcon Research, Ltd.