NCT00761995已完成4 期
Safety and Efficacy of Brinzolamide Dosed TID With Dorzolamide Dosed TID in Reducing Intraocular Pressure in Patients With Open Angle Glaucoma or Ocular Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- IOP reduction from baseline at the end of 12 weeks
研究概览
简要总结
Safety and Efficacy of Brinzolamide Dosed TID With Dorzolamide Dosed TID in Reducing Intraocular Pressure in Patients With Open Angle Glaucoma or Ocular Hypertension
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Male and females 18 years of age or older, diagnosed with primary open-angle glaucoma or ocular hypertension.
- •If of child bearing potential
- •* Must use a reliable means of contraception for the duration of the study or surgically sterilized.
- •Must have a negative pregnancy test.
- •Must be non-lactating
- •IOP measurements ≥ 24 ≤ 36 mm Hg, in at least one eye, at 9.00 a.m and ≥ 21 ≤ 36 mm Hg in at least one eye (the same eye) at 11.00 am measurement
- •The IOP criteria to be met at both time points by the same eye
- •Visual Acuity of 6/24 or better in study eye (s)
- •Gonioscopy angle of ≥ 2 in the study eye (s)
- •Patients with a level of understanding and willingness to fully comply with all visits and study procedures scheduled by the study site as evidenced by written informed consent
排除标准
- •Patients with one sighted eye or amblyopia
- •History of chronic or recurrent uveitis or other inflammatory eye disease (e.g. scleritis).
- •History of ocular infections (e.g. conjunctivitis) within past 3 months.
- •History of ocular trauma within the past 6 months.
- •History of severe or progressive retinal (i.e. retinal degeneration, diabetic retinopathy, retinal detachment or retinal tears) or optic nerve disease.
- •History of severe ocular pathology such as severe glaucoma damage determined by optic nerve head (e.g. C/D ratio > 0.8) or visual field evaluation (e.g. split fixation, clinically significant field loss within the central field) or legal blindness in either eye.
- •Intraocular surgery within the past 12 months or Laser surgery within the past 3 months as determined by patient history and/or examination.
- •Any other form of glaucoma other than primary open angle glaucoma.
- •Inability to discontinue contact lens wear during the day
- •History of hypersensitivity to oral or topical CAIs, sulfonamide drugs or to any component of these medicines.
- •Any abnormality preventing reliable applanation tonometry of either eye.
- •Patients who are in the investigator's best judgement at risk of visual field or visual acuity worsening as a consequence of participation of trial.
- •Chronic use of any systemic medication that may effect IOP with less than one month stable dosing regimen (i.e. sympathomimetic agents, beta-adrenergic blocking agents, alpha agonists, alpha-adrenergic blocking agents, calcium channel blockers, angiotensin-converting enzyme inhibitors, etc.).
- •Current use of any ophthalmic, dermatologic or systemic steroid.
- •Patients with clinically significant medical (acute or progressive) condition e.g. cardiovascular, pulmonary, hematologic disease or psychiatric illness, who are unlikely to fully complete all protocol requirements as assessed by the investigator.
- •Participation in another clinical trial within past 30 days.
- •Pregnant and lactating females
研究组 & 干预措施
Azopt
Active Comparator
topical eye drop dosed 1 drop 3 times daily
干预措施: Azopt (Drug)
Cosopt
Active Comparator
topical eye drop
干预措施: Cosopt (Drug)
结局指标
主要结局
IOP reduction from baseline at the end of 12 weeks
时间窗: 12 weeks
次要结局
- IOP reduction from baseline at the end of 4 and 8 weeks of treatment(4 and 8 weeks)
研究者
研究点 (1)
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