ISRCTN80385690已完成不适用
Comparison of the Clinical Efficacy and Tolerability of Latanoprost RDR 0.005% Eye Drops Test Formulation of RDR Pharma GmbH, Germany, for the Treatment of Ocular Hypertension and Primary Open Angle Glaucoma with Xalatan® 0.005% Eye Drops: A multicenter, randomized, investigator-blind clinical trial with parallel groups
RDR Pharma GmbH (Germany)0 个研究点目标入组 260 人开始时间: 2010年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 260
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Unilateral or bilateral ocular hypertension or primary open angle glaucoma at an early stage
- •2. In at least one eye, IOP = 22 mmHg at 8am and IOP = 30 mmHg at 8 am, 12 noon and 4 pm under the following conditions:
- •2.1. untreated ocular hypertension, or
- •2.2. 4 week washout period of an initial monotherapy with a prostaglandin or beta-blocker
- •3. Best corrected visual acuity = 20/100 (Snellen) or 2/10 (Monoyer)
- •4. Male and female patients, age = 18 years
- •5. Female subjects of childbearing age must be using a medically accepted form of birth control and must have a negative urine pregnancy test at screening
- •6. Able to provide informed consent after risks and benefits of the study have been explained
- •7. Ability to communicate effectively with study personnel
- •8. Written informed consent
排除标准
- •1. In both eyes, IOP < 22 mmHg
- •2. IOP > 30 mmHg
- •3. Known sensitivity to latanoprost or any component of the drug products
- •4. Use of contact lenses
- •5. Other defined ocular diseases, ocular interventions, or ocular medications
- •6. Pregnancy or breastfeeding
- •7. Other defined diseases such as dysfunction of the liver or the kidneys, cancer, angina pectoris, asthma bronchiale, haematological diseases
- •8. Current or anamnestic drug addiction or extensive alcohol use
- •9. Participation in another clinical study within 4 weeks prior to enrolment
- •10. History of non-compliance
- •11. Any condition that compromises the ability to understand or comply with study requirements
- •12. Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
研究者
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