NCT05022004已完成3 期
Therapeutic Equivalence Study of Generic Brinzolamide 1% Ophthalmic Suspension Compared to Reference Listed Drug Azopt® (Brinzolamide) Ophthalmic Suspension 1% in Subjects With Primary 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
- 599
- 试验地点
- 34
- 主要终点
- Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups
研究概览
简要总结
This is a randomized, Investigator-masked, multi-center, parallel group, therapeutic equivalence study with clinical endpoint.
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
- Triple (Participant, Investigator, 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 nonpregnant female aged 18 years or older with chronic open angle glaucoma or ocular hypertension in both eyes.
- •Provide signed and dated informed consent in accordance with good clinical practice and local legislation prior to any study procedure.
- •Be able and willing to follow study instructions and complete all required visits.
- •Subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.
排除标准
- •Subjects with angle closure glaucoma
- •Females who are pregnant, breast feeding, or planning a pregnancy.
- •Females of childbearing potential who do not agree to utilize an adequate form of contraception.
- •Current, or past history of, severe hepatic or renal impairment
- •Current, or history within 2 months prior to baseline of, significant ocular disease
- •Functionally significant visual field loss
- •Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy
- •Subjects currently in another clinical trial
研究组 & 干预措施
BRIN-20-01
Experimental
干预措施: Brinzolamide ophthalmic suspension (Drug)
Azopt®
Active Comparator
干预措施: Azopt® (Drug)
结局指标
主要结局
Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups
时间窗: Baseline, Week 2 & Week 6
The recommended primary endpoint is the mean difference in Intraocular Pressure of both eyes between the two treatment groups at pre-specified time points.
次要结局
- Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups.(approximately 8:00 AM. (hour 0; before the morning drop) and 10:00 AM. (hour 2) at the Day 14 (Week 2) and Day 42 (Week 6) visits)
研究者
研究点 (34)
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