NCT00878917已完成3 期
Randomized, Double-Masked, Active Controlled, Crossover Phase III Equivalence Study of Dorzolamide 2% Eye Drops Solution In Subjects With Open Angle Glaucoma Or Ocular Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- intraocular pressure (IOP)-lowering
研究概览
简要总结
The study aims to prospectively prove the equivalence of the test product and the reference solution in lowering intraocular pressure in patients with open angle glaucoma and ocular hypertension. For this purpose the patients are randomized into two sequences of study drug administration in a crossover study with an adequate wash-out period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients of any race aged 18 years or older
- •A clinical diagnosis of open angle glaucoma, pseudoexfoliation or pigment dispersion glaucoma, or ocular hypertension in one or both eyes
- •IOP controllable on one drug treatment in the study eye in way that assures clinical stability of vision and the optic nerve throughout the study
- •Baseline IOP between 18 and 32 mmHg in the study eye (in eyes not included in the study IOP must have been controllable on no pharmacologic treatment or on the study medicine only)
- •Best corrected visual acuity of 20/200 or better in the study eye(s)
- •Ability of subject to understand character and individual consequences of clinical trial
- •Signed and dated informed consent of the subject must be available before start of any specific trial procedures
- •Women with childbearing potential have to practicing a medically accepted contraception during trial and a negative pregnancy test (serum or urine) should be existent before trial. Reliable contraception are systemic contraceptives (oral, implant, injection) and diaphragm or condoms with spermicidal. Women that are sterile by surgery or for more than two years postmenopausal can be participate in the trial.
排除标准
- •Chronic or recurrent inflammatory eye disease
- •Ocular trauma within the past six months
- •Current ocular infection, i.e. conjunctivitis or keratitis
- •Any abnormality preventing reliable applanation tonometry
- •Intraocular surgery or laser treatment within the past three months
- •Inability to discontinue contact lens wear during the study
- •Use of any systemic medication that would affect IOP with less than a
- •1-month stable dosing regimen before the screening visit
- •Pregnancy and lactation
- •History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
- •Participation in other clinical trials during the present clinical trial or within the last four weeks
- •Medical or psychological condition that would not permit completion of the trial or signing of informed consent
- •Subject is allergic to sulfonamides
- •Severe renal dysfunction or hyperchloraemic acidosis
研究组 & 干预措施
Dorzolamide
Experimental
干预措施: Dorzolamide 2 % eye drops solution (Drug)
结局指标
主要结局
intraocular pressure (IOP)-lowering
时间窗: 9 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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