Phase II, National, Multicenter, Randomized, Double Blind Clinical Trial, to Evaluate the Efficacy and Safety of Saturno IIB Association on the Control of Ocular Inflammation Post-phacoemulsification
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Control of ocular inflammation post-phacoemulsification as evaluated though the presence of cells in the anterior chamber
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Saturno II association on the control of ocular inflammation post-phacoemulsification
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants of both sexes, aged 18 years or more;
- •Participants presenting the diagnosis of cataract with indication for surgery by the phacoemulsification procedure;
- •Participants who undergo surgery in only 1 eye at a time;
- •Participants with intraocular pressure (IOP) ≤ 20 mmHg;
- •Signed consent.
排除标准
- •Used non-steroidal anti-inflammatory drugs or topical steroids or systemic inhalers within 21 days prior to randomization of the clinical trial;
- •Performing the surgery for the second time, to correct the previous procedure or to change the lens;
- •Decompensated glaucoma or ocular hypertension with IOP above 21 mmHg;
- •Active ocular infectious diseases;
- •History hypersensitivity to the active ingredients used in the study;
- •Pregnancy or risk of pregnancy and lactating patients;
- •History alcohol abuse or illicit drug use;
- •Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
- •Participation in clinical trial in the year prior to this study.
研究组 & 干预措施
Vigadexa®
1 drop, 4 times a day, in the eye to be operated, 1 day before surgery until 15 days after surgery
干预措施: Vigadexa® (Drug)
SATURNO II
1 drop, 4 times a day, in the eye to be operated, 1 day before surgery until 15 days after surgery
干预措施: SATURNO II association (Drug)
结局指标
主要结局
Control of ocular inflammation post-phacoemulsification as evaluated though the presence of cells in the anterior chamber
时间窗: 16 days
The inflammation will be evaluated though the presence of cells in the anterior chamber. For this, the number of cells per high-power field in the anterior chamber was counted and recorded on a scale where 0 indicates ≤ 5 cells, 1 = 5 to 10 cells, 2 = 11 to 20 cells, 3 = 21 to 50 cells, and 4 corresponds to ≥ 50 cells.
次要结局
- Incidence and severity of adverse events recorded during the study(26 days)