NCT00832377已完成2 期
Prospective, Open-label, Single-arm Study to Evaluate Efficacy and Safety of Combination Therapy of Timolol and Dorzolamide (COSOPT) as Initial Treatment for Patients With Normal Tension Glaucoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 主要终点
- Mean Change in the Peak Intraocular Pressure (IOP) Measured Two Hours After Study Drug Administration at Week 12 Compared to Baseline IOP.
研究概览
简要总结
A study to evaluate the effect of the 12-week treatment with timolol/dorzolamide combination eyedrops (COSOPT) on decrease in intraocular pressure (IOP) at 2 hours after the study drug administration
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients who have not been treated with a glaucoma medication within 6 weeks prior to study participation after diagnosis with primary open-angle glaucoma
- •Patients with primary open-angle glaucoma based on gonioscopy
- •Patients with normal tension glaucoma diagnosed based on accompanying optic disc cupping and reappearance of visual field defect corresponding to retinal nerve fiber layer defect.
- •Subjects with < 22 mm Hg of diurnal IOP measured using Goldmann applanation tonometer (every two hours between 9 a.m. and 5 p.m.)
排除标准
- •Patients with another type of glaucoma but primary open-angle glaucoma
- •Patients treated with other glaucoma medications within 6 weeks prior to study participation
- •Patients with a history of chronic ocular inflammation or recurrent ocular inflammation
- •Patients using contact lenses
- •Patients who are allergic to timolol or dorzolamide
- •Patients with a history of any of the following COSOPT (timolol/dorzolamide combination) contraindications:
- •Reactive airway diseases
- •Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock
- •Severe renal impairment
- •Patients with a history of significant ocular trauma or intraocular surgery within 6 months before participating the study, or intraocular laser surgery within 3 months before the participating the study
- •Patients with a history of a corneal disease
- •Patients who are using steroid or used the drug for more than 2 weeks within 12 months before participating the study
- •Pregnant women
研究组 & 干预措施
Timolol/Dorzolamide
Experimental
Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
干预措施: timolol/dorzolamide combination (Drug)
结局指标
主要结局
Mean Change in the Peak Intraocular Pressure (IOP) Measured Two Hours After Study Drug Administration at Week 12 Compared to Baseline IOP.
时间窗: Baseline and 12 weeks
The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement. IOP was measured in both eyes and the eye with the higher IOP was used for the participant.
次要结局
- Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP.(Baseline and 12 weeks)
- Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP(Baseline and 12 weeks)
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