EUCTR2015-002131-18-DE进行中（未招募）1 期
A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients withOpen-Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 210
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
- •Male or female, 18 years of age or older
- •Written informed consent and authorization for use and release of personal health information are obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information [United States (US) sites] and written Data Protection consent [European Union (EU) sites])
- •In the investigator’s opinion, patient’s IOP is not adequately managed with topical medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence)
- •In the investigator’s opinion, both eyes can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog (eg, LUMIGAN, Xalatan®, Travatan®) eye drops as the sole therapy if medication was taken as directed
- •In the investigator’s opinion, patient’s IOP can be adequately managed with SLT monotherapy
- •In the investigator’s opinion, patient is a suitable candidate for SLT
- •Diagnosis of either OAG (ie, primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or OHT in each eye, requiring bilateral IOP-lowering treatment (Note: diagnosis does not have to be the same in both eyes)
- •Central endothelial cell density by specular microscopy confirmed as being qualified by Reading Center assessment prior to beginning Washout
- •The iridocorneal angle must be independently confirmed as being qualified by 2 ophthalmologists using the following criteria:
- •o Shaffer Grade = 3 on clinical gonioscopy of the inferior angle
- •o Peripheral anterior chamber depth by Van Herick examination = 1/2 corneal thickness
- •Note: The independent eligibility assessments must both agree that the Shaffer grade is = 3 and the Van Herick grade is = 1/2 corneal thickness.
- •At the Baseline visit (8:00 AM ± 1 hour), IOP of = 22 and = 34 mm Hg, with difference between eyes of = 5 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 132
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 78
排除标准
- •History of previous laser trabeculoplasty
- •The following surgical history:
- •a. History or evidence of complicated cataract surgery: eg, surgery resulting in complicated lens placement (such as anterior chamber intraocular lens implant (IOL; sulcus IOL; aphakia etc) or intraoperative
- •complications (such as a posterior capsular tear [with or without vitreous loss], substantial iris trauma, etc)
- •Note: history of uncomplicated cataract surgery is not an exclusion.
- •b. History of phakic IOL insertion for refractive error correction
研究者
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