CTRI/2017/04/008299已完成3 期
A Multicentric, Double Blind, Randomized, Active Control, Parallel Group Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Nepafenac Ophthalmic Suspension 0.3 % w/v Vs. Bromfenac Ophthalmic Solution 0.09% w/v in the treatment of Patients with Pain and Inflammation in the Eye associated with Cataract Surgery.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 18
- 主要终点
- Ocular inflammation as assessed by the investigator during slit lamp examination
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 Nepafenac Ophthalmic Suspension 0.3 % w/v Vs.Bromfenac Ophthalmic Solution 0.09% w/v in the treatment of Patients with Painand Inflammation in the Eye associated with Cataract Surgery.
Primary objective of this study is to assess Ocularinflammation. Secondary objective of the study is to assess the Ocular pain andnumber of patients pain free at each visit post cataract surgery.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and Female patients of age
- •70 years (Both inclusive). 2.Planned cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens. 3.Voluntary willingness to give written informed consent prior to participation in trial.
排除标准
- •1.Use of topical ocular, inhaled or systemic nonsteroidal anti-inflammatory drugs within 7 days of surgery, with the exception of the allowed low dose of aspirin (up to 100 mg) prior to surgery and through study exit.
- •2.Use of any form of steroids -topical, inhaled or systemic steroids within 14 days prior to surgery or local or oral NSAIDs within 7 days of surgery.
- •3.History of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the operative eye.
- •4.Pregnant and lactating women.
- •5.Known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), or to any component of the test article.
- •6.Subjects with bleeding tendency, dry eye, rheumatoid arthritis, ocular surface disease including epithelial problems.
- •7.Subject with any surgery which converted from phacoemulsification to extra capsular surgery.
- •8.Patients with history of ocular surgery, inflammatory eye disease, ocular infection, congenital ocular anomalies, ocular trauma or current signs and symptoms that were associated with these or other ocular conditions.
- •9.Lens pseudoexfoliation syndrome with glaucoma or zonular compromise or previous ocular trauma.
- •10.Patients were also excluded if their IOP could not be reliably measured or had planned multiple surgical procedures, lens pseudoexfoliation syndrome with glaucoma or zonular compromise in the operative eye, ocular or systemic inflammatory or diabetic disease, or previous ocular trauma to the operative eye.
- •11.Patient with Diabetic Retinopathy, Glaucoma and any other Neurological condition.
- •12.Any other condition(s) that may affect the procedure of the study.
结局指标
主要结局
Ocular inflammation as assessed by the investigator during slit lamp examination
时间窗: Day 1,Day 7,Day 14
次要结局
- Ocular pain will be assessed using a categorical scale.(Percentage of patients Pain Free at each visit post cataract surgery.)
研究者
研究点 (18)
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