EUCTR2014-003037-26-AT进行中（未招募）1 期
The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
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
入选标准
- •Written informed consent has been obtained
- •In the opinion of the investigator, based on prior use or on IOP rebound (elevation) during the washout
- •period, patient is a responder to IOP lowering by topical prostamides, prostaglandins, or prostaglandin
- •The iridocorneal angle in the study eye must be independently confirmed as being qualified as being qualified by 2 opthalmologists using the following criteria:
- •- Shaffer Grade > 3 on clinical gonioscopy of the inferior angle
- •- Peripheral anterior chamber depth by Van Herick examination = 1/2
- •corneal thickness
- •By the Baseline visit, the final central endothelial cell density in both eyes must be confirmed as being
- •qualified by Reading Center assessment
- •Diagnosis of either OAG (ie, primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or
- •OHT in each eye, and both eyes require IOP-lowering treatment (Note: diagnosis does not have to be the same in both eyes)
- •In the investigator’s opinion, either eye can be treated adequately with topical ophthalmic beta-blocker (eg. timolol) eye drops as the sole therapy
- •At the baseline visit: Hour 0 IOP in the study eye of = 22 mm Hg and = 32 mm Hg, and in the fellow eye of = 32 mm Hg
- •At the baseline visit: Hour 2 IOP in the study eye of = 19 mm Hg and = 32 mm Hg, and in the fellow eye of = 32 mm Hg
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •History of cataract surgery in the study eye resulting in anterior chamber intraocular lens implant (IOL), phakic IOL, sulcus IOL, aphakia, or complications (eg, a posterior capsular tear [with or
- •without vitreous loss], iris trauma, etc)
- •In the investigator’s opinion, patient is nonresponsive to topical ophthalmic beta-blockers and /or topical prostamides, prostaglandins, or prostaglandin analogs (eg Lumigan, Xalatan, Travatan)
- •Contraindications to beta-blocker therapy
研究者
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