Evaluation of the Safety and Efficacy of VIGADEXA Ophthalmic Gel Compared to VIGADEXA Ophthalmic Solution in Preventing Inflammation and Infection Following Cataract Surgery
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Percentage of patients with no clinically evidenced bacterial infection
研究概览
简要总结
The purpose of this study is to compare VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.075%) ophthalmic gel to VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.1%) ophthalmic solution in the prevention of postoperative inflammation and infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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
- •18 years of age or older.
- •Diagnosis of cataract with intention to undergo routine, uncomplicated cataract surgery.
- •Able to understand and sign an informed consent form.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Glaucoma or ocular hypertension.
- •Use of topical or systemic non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to surgery or planned use during the study. Low-dose acetylsalicylic acid (up to 100 mg/day) is allowed.
- •Use of anti-bacterial, anti-viral, or anti-fungal agents or ocular medications within 30 days prior to enrollment in the study or during study, as specified by protocol.
- •Secondary implantation or replacement of the intra-ocular lens (IOL) in the study eye.
- •Planned use of contact lenses in the study eye during the study period.
- •Cataract surgery in the contralateral eye within 30 days prior to the Screening Visit, or planned for the 3 weeks after the cataract surgery in the study eye.
- •History of clinically significant trauma to the study eye within the past 12 months.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
VIGADEXA Gel
VIGADEXA ophthalmic gel topically administered TID to the operative eye starting the day before surgery, continuing on the day of surgery, and for 15 days following surgery.
干预措施: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel) (Drug)
VIGADEXA Solution
VIGADEXA ophthalmic solution topically administered QID to the operative eye starting the day before surgery, continuing on the day of surgery, and for 15 days following surgery.
干预措施: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution) (Drug)
结局指标
主要结局
Percentage of patients with no clinically evidenced bacterial infection
时间窗: Day 15 post-operative
As assessed by the investigator during slit-lamp examination.
Percentage of patients with a score of 0 (<5 cells) for cells in the anterior chamber
时间窗: Day 15 post-operative
As assessed by the investigator during slit-lamp examination.
次要结局
- Cells in the anterior chamber (study eye)(Day 15 post-operative)
- Ocular pain (study eye)(Day 15 post-operative)
- Inflammatory reaction (study eye)(Day 15 post-operative)