CTRI/2009/091/000578已完成3 期
A Multicenter, Open Label, Active Control, Parallel-Group Randomized Study to Demonstrate Non Inferiority of Brinzolamide 1% Ophthalmic Suspension compared With Dorzox (Dorzolamide) 2% Ophthalmic Solution in Treatment of Elevated Intra-Ocular Pressure in Patients with Primary Open Angle Glaucoma or Ocular Hypertension
Alcon Laboratories India Pvt Ltd7 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2009年11月2日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- IOP reduction from baseline
研究概览
简要总结
This is a multicenter, open label, active control, parallel-group randomized study to compare the reduction of elevated intra-ocular pressure (IOP) in patients with primary open angle glaucoma or ocular hypertension. 200 patients with primary open angle glaucoma or ocular hypertension will be randomized to receive either the test or the comparator drug, instilled in the eye three times daily for a period of 12 weeks. The primary outcome measure is to demonstrate IOP reduction from baseline and demonstrate non inferiority of brinzolamide (test) 1% ophthalmic suspension compared with Dorzox (dorzolamide - comparator) 2% ophthalmic solution.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
入选标准
- •1.Male and females 18 years of age or older, diagnosed with primary open-angle glaucoma or ocular hypertension.2.IOP measurements ≥ 24 ≤ 36 mm Hg, in atleast one eye, at 9.00 am and ≥ 21 ≤ 36 mm Hg in atleast one eye (the same eye) at 11.00 am measurement.
排除标准
- •Patients with one sighted eye or amblyopia, history of chronic or recurrent inflammatory eye disease, ocular infections (3 months), ocular trauma, severe or progressive retinal or optic nerve disease, severe ocular pathology, intraocular surgery (last 12 months), laser surgery (last 3 months), current use of steroids or presence of any other form of glaucoma other than primary open angle glaucoma.
结局指标
主要结局
IOP reduction from baseline
时间窗: 12 weeks
次要结局
- IOP reduction from baseline(4 and 8 weeks)
研究者
研究点 (7)
Loading locations...
相似试验
招募中
3 期
Study of LY01610 in Patients With Recurrent Small Cell Lung CancerRelapsed Small Cell Lung CancerNCT06128837Luye Pharma Group Ltd.686
已完成
3 期
Comparative Study of BAY86-5300 With a Flexible Extended Regimen for DysmenorrheaDysmenorrheaNCT01892904Bayer216
已完成
3 期
A clinical trial to study the effect of FDC of Azelastine and Mometasone Nasal Spray in Patients with Seasonal Allergic Rhinitis (symptoms similar to those of a cold such as runny nose and sore throat, caused by an allergic reaction to an allergen such as dust, plant pollens or animal dander)CTRI/2013/01/003334Glenmark Pharmaceuticals Ltd560
未知
3 期
A clinical trial to study the effects of two drugs, Fixed dose combination of tablets of Rosuvastatin 5 mg and Fenofibrate 160mg with Rosuvastatin 5mg alone in patients with dyslipidemiaDyslipidemiaCTRI/2010/091/000147M/s. Ravenbhel Healthcare Pvt. Ltd.200
已完成
3 期
Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody TreatmentParoxysmal Nocturnal Hemoglobinuria (PNH)NCT04558918Novartis Pharmaceuticals97
