CTRI/2010/091/001459已完成3 期
A Comparative, Randomized, Double Blind, Multicentric, Prospective Clinical Study to evaluate the efficacy, safety and tolerability of Tafluprost Ophthalmic solution 15 mcg/ml Vs. Latanoprost eye drops 0.005 % in patients with Glaucoma.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Blurred Vision, Halos around Lights, Pain and Redness of Eye.
研究概览
简要总结
This study is a randomized, comparative, Double blind and multicentric clinical study comparing the safety and efficacy of Tafluprost Ophthalmic solution Vs. Latanoprost eye drop in 200 patients with Glaucoma. Date of first enrollment will be 13 Oct 2010.
Primary efficacy parameters will be mean Values of IOP levels and Ocular signs and symptoms such as Blurred vision, halos around lights, pain and redness of eyes will be assessed at baseline visit, all follow up visits and at final visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator 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
- •1.Patients with diagnosis of glaucoma.
排除标准
- •Pregnant or nursing females.Patients with exfoliation glaucoma and neovascular glaucoma.
- •Patients with diabetic retinopathy.
- •Patients with advanced visual field loss (MD <-15dB).Excessive myopia (<-6D).Any corneal abnormality or other condition preventing reliable applanation tonometry.Presence of any external disease and inflammation of the eye.History of refractive surgery.History of laser trabeculoplasty, filtering surgery, trabeculotomy, cataract surgery, and other intraocular surgery.
结局指标
主要结局
Blurred Vision, Halos around Lights, Pain and Redness of Eye.
时间窗: Day 1, week 1, week 2 and week 4.
次要结局
- Overall global assessment of efficacy and tolerability(Week 4)
研究者
研究点 (4)
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