The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension

Allergan Limited0 个研究点目标入组 600 人开始时间: 2015年1月26日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•-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 analogs
•-The iridocorneal angle inferiorly in the study eye must be confirmed as being qualified by Reading
•Center AS-OCT assessment
•-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
•- In the investigator´s opinion, either eye can be treated adequately with timolol eye drops as the sole
•therapy- In both eyes, at the baseline visit: Hour 0 IOP of >= 22 mm Hg and <= 32 mm Hg, with difference between eyes of <= 5 mm Hg
•- In both eyes at Hour 2 at the baseline visit, IOP >= 19 mm Hg and <= 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

•- 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
•- Contraindications to beta-blocker therapy

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