A Clinical Study to evaluate the Efficacy , Safety and Tolerability of Brinzolamide 1.0% w/v plus Brimonidine Tartrate 0.2 % w/v Ophthalmic Suspension Vs. Brinzolamide 1% eye drops in patients with Open-Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 232
- 试验地点
- 21
- 主要终点
- •The primary end point for assessing efficacy will be the reduction in IOP (Intraocular Pressure) measured by Tonometry
研究概览
简要总结
This study is a multicentric, double blind, randomized, active control, parallel group comparative Study to evaluate the Efficacy, Safety and Tolerability of Brinzolamide 1.0% w/v plus Brimonidine Tartrate 0.2% w/v Ophthalmic Suspension Vs. Brinzolamide 1% eye drops in patients with Open Angle Glaucoma or Ocular Hypertension. The Study is proposed to start on 12.06.15. The following primary outcome will be measured at Day 1,at the end of 1st 2nd, 4th, 8th and 12th week of treatment for clinical assessment: The mean reduction in IOP of the treatment groups will be assessed using descriptive statistics. The improvement in IOP from baseline to the end of treatment period will be compared by Chi square test. The secondary outcome will be measured as Percentage of patients reaching the defined IOP (intraocular pressure) <20 mmHg for general population, and ≤20 mmHg for elderly) at the final visit of the study and Percentage of patients reporting AE and/or SAE during thestudy.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢A clinical diagnosis of glaucoma or Ocular hypertension at least in at one (study) eye.
- •â€¢IOP between 21 to less tnan and equal 36 mm of Hg. •Freshly diagnosed patients of open angle glaucoma or ocular hypertension, Patients who are previously diagnosed and on treatment for open angle glaucoma or ocular hypertension will undergo washout period, Miotics (7 days), Alpha Agonist and Alpha/beta agonist (14 days), β antagonist and prostaglandin analogs (21 days).
- •Subject with H/O discontinued Carbonic anhydrase inhibitor since past 4 months.
- •â€¢Voluntary willingness to give written informed consent prior to participation in trial.
排除标准
- •Any history of: •Ocular trauma or intraocular surgery within the past 6 months; •Ocular infection, inflammation, or laser surgery within the past 3 months; Any present observation of: •Chronic, recurrent or severe inflammatory eye disease.
- •â€¢Central cornea thickness 620 mm, as measured by pachymetry, in either eye.
- •â€¢Shaffer angle grade less than 2 in either eye (range, 0 [complete or partial closure] to 3 [wide open angle, more than 20]), as measured by Gonioscopy.
- •â€¢Severe central visual field loss in either eye measured by Perimetry.
- •â€¢Clinically significant or progressive retinal disease.
- •â€¢Best-corrected visual acuity worse than 0.6 logMAR (Best Corrected VA score worse than 55 ETDRS letters (20/80 Snellen equivalent).
- •â€¢Other ocular pathology (including severe dry eye) that may preclude the administration of an alpha-adrenergic agonist and/or a topical CAI.
- •â€¢Patients with broken rear lens capsule or anterior eye lenses or in patients with known risk factors for cystoid macular edema or iritis / uveitis.
- •â€¢Patients who are required to wear contact lens during the study period.
- •â€¢Cup/disc ratio greater than 0.80.
结局指标
主要结局
•The primary end point for assessing efficacy will be the reduction in IOP (Intraocular Pressure) measured by Tonometry
时间窗: 1st week, 2nd week, 4th week, 8th week, 12th week
次要结局
- •Percentage of patients reporting AE and/or SAE during the study.(12th week)
- •Percentage of patients reaching the defined IOP (intraocular pressure) 20 mmHg for general population, and ≤20 mmHg for elderly)(12th week)