CTRI/2023/12/060575尚未招募Unknown
A Non-randomized, Non-Interventional, Prospective, Multicenter, Post Marketing Surveillance Study to Assess the Antibacterial Effectiveness and Safety of 0.5% Moxifloxacin Hydrochloride Ophthalmic Solution in Perioperative (Preoperative and Postoperative) Sterilization in Patients Undergoing Ophthalmic Surgery
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 102
- 试验地点
- 10
- 主要终点
- 1. To measure the post-op endophthalmitis infection rate
研究概览
简要总结
The purpose of this study is to generate additional safety and effectiveness data on 0.5 % Moxifloxacin Hydrochloride solution in Indian patients who are undergoing ophthalmic surgery that more closely resemble the real-world population intended to be treated. This study is being conducted as part of the post-marketing regulatory commitment to the Indian Health authority.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients > 18 years of age, who have been prescribed 0.5% Moxifloxacin drops preoperatively (2 days) and postoperatively for 2 weeks after ocular surgery Patient or legally acceptable representative (LAR) willing to voluntarily provide signed informed consent for participation in the study.
排除标准
- •Patients with known history of hypersensitivity to fluoroquinolones Novartis Confidential Page 14 Non-Interventional Study Protocol v00 CUKG489C1IN01 Patients with history of serious underlying ocular or systemic disease or complication before surgery Patients diagnosed with an extraocular bacterial, viral, fungal infection prior to surgery Patients who have been administered other topical antibacterial agents within 24 hours of Moxifloxacin administration or systemic antibacterial agents within 72 hours of Moxifloxacin administration Patients who have planned to undergo cataract surgery in both eyes on same day Patients who have participated in another clinical study within 30 days prior to the start of this study Pregnant women/lactating mothers/ women suspected to be pregnant.
结局指标
主要结局
1. To measure the post-op endophthalmitis infection rate
时间窗: 1. To measure the post-op endophthalmitis infection rate upto day fourteen
次要结局
- To confirm endophthalmitis & assess clinical signs of other postoperative infections on Days 1, 7 and 14 after surgery.(Diagnosis of suspected endophthalmitis patients using microbiological culture & Gram stain of aqueous & vitreous fluids)
研究者
研究点 (10)
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