CTRI/2023/12/060575尚未招募4 期
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 - VIGAMOX
ovartis Healthcare Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
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
研究者
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