A Descriptive Comfort Study of Brinzolamide 1% / Brimonidine Tartrate 0.2% Fixed Combination Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension and Brimonidine Tartrate 0.2% Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 103
- 主要终点
- Mean Ocular Discomfort Score
研究概览
简要总结
The purpose of this study was to describe the ocular discomfort immediately upon instillation of Brinzolamide 1%/Brimonidine 0.2% Tartrate Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension, and Brimonidine Tartrate 0.2% Ophthalmic Solution in subjects with open-angle glaucoma and/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
- 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
- •Sign Informed Consent document.
- •Diagnosis of open-angle glaucoma or ocular hypertension
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
- •Severe central vision loss in either eye.
- •Any chronic or recurrent inflammatory eye disease.
- •Ocular trauma within the preceding 6 months.
- •Ocular infection or ocular inflammation within the preceding 3 months.
- •Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
- •Any intraocular surgery within the preceding 6 months.
- •Any ocular laser surgery within the preceding 3 months.
- •History or current evidence of severe illness or any other conditions which would make the subject, in the opinion of the Investigator, unsuitable for the study.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Brinz/Brim
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
干预措施: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension (Drug)
Brinzolamide
Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
干预措施: Brinzolamide ophthalmic suspension, 1% (Drug)
Brimonidine
Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
干预措施: Brimonidine tartrate ophthalmic solution, 0.2% (Drug)
结局指标
主要结局
Mean Ocular Discomfort Score
时间窗: Week 1
Ocular discomfort was assessed by the subject immediately following the 8 AM instillation of study drug and rated on a 5-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe).
次要结局
未报告次要终点