Comparative study for efficacy and safety of fixed drug combination between Timolol Maleate(0.5 percent) plus Brinzolamide(1 percent) and Timolol Maleate (0.5 percent) plus Brimonidine Tartrate(0.2 percent) in Primary Open Angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Efficacy:
研究概览
简要总结
Study design: Prospective comparative study
Study duration: 1.5 years
• Participants: Patients with POAG
• Drugs Used: Timolol with Brinzolamide and Timolol with Brimonidine
SAMPLE SIZE : 50 patients in each group (total 100 patients)
-Group I: Patients of POAG treated with FDC of Timolol + Brinzolamide
-Group II: Patients of POAG treated with FDC of Timolol + S Brimonidine
• Outcome Measures: evaluation at baseline(0).
Follow up at 2nd week, 1 month,3 months and 6 months for efficacy and safety
Efficacy:
IOP reduction in mmHg
Optic disc changes
Visual field changes
RNFL
Safety:
Tolerability/adverse reactions
Side effects
Data analysis:
-Paired t-test and unpaired t-test for IOP reduction comparison
-Chi-square test for adverse events
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Freshly diagnosed primary open angle glaucoma patients 2.Intraocular pressure more than or equal to 21mmHg 3.Patients already being treated with study drug 4.Age more than 20 years.
排除标准
- •1.Patients on or requiring systemic or topical anti-glaucoma medications other than these two Fixed Drug Combinations 2.Patients with Best Corrected Visual Acuity less than 6/60 3.Patients with Secondary open angle glaucoma 4.Cataract surgery within 3 months of study 5.Pre-existing macular and retinal pathologies,ocular surgery,ocular trauma 6.Known allery to Sulfa group 7.History of hypersensitivity to any of the study medication or their products 8.Contact lens users 9.Pregnant women.
结局指标
主要结局
Efficacy:
时间窗: Evaluation at baseline (0) visit, follow up at 2nd week,1 month,3 months and 6 months for efficacy and safety
-IOP reduction in mmHg
时间窗: Evaluation at baseline (0) visit, follow up at 2nd week,1 month,3 months and 6 months for efficacy and safety
-Optic disc changes
时间窗: Evaluation at baseline (0) visit, follow up at 2nd week,1 month,3 months and 6 months for efficacy and safety
-Visual field changes
时间窗: Evaluation at baseline (0) visit, follow up at 2nd week,1 month,3 months and 6 months for efficacy and safety
-RNFL by OCT
时间窗: Evaluation at baseline (0) visit, follow up at 2nd week,1 month,3 months and 6 months for efficacy and safety
Safety
时间窗: Evaluation at baseline (0) visit, follow up at 2nd week,1 month,3 months and 6 months for efficacy and safety
-tolerability/adverse reactions
时间窗: Evaluation at baseline (0) visit, follow up at 2nd week,1 month,3 months and 6 months for efficacy and safety
-Side effects
时间窗: Evaluation at baseline (0) visit, follow up at 2nd week,1 month,3 months and 6 months for efficacy and safety
次要结局
- To compare compliance of both Fixed Drug Combination(baseline , 2nd week,1 month,3 months & 6 months)
研究者
Khushi Macwan
GCS Medical College,Hospital and Research Centre