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
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Post-op endophthalmitis rate up to Day 14
研究概览
简要总结
This is a non-interventional, uncontrolled, prospective, multicenter, post marketing surveillance study.
详细描述
The study treatment i.e., 0.5% Moxifloxacin hydrochloride ophthalmic solution will be prescribed as per approved label; the assignment of the patient to the therapy will be decided within the current practice and the medical indication and will clearly be separated from the decision to include the patient in the study.
The treatment period for each patient will be maximum 17 days from start of Moxifloxacin treatment. Study visit will be 1 day prior to surgery, day of surgery (Day 0) and 1 (day of surgery / post surgery), 7, and 14 days post-op (Note: Since its non-interventional study, the eligibility confirmation can be 1 or 2 days prior to the surgery depending on investigator's discretion).
After the patients sign the informed consent, the patients will be advised to start with Moxifloxacin ophthalmic solutions 2 days prior to the surgery and will be advised to administer it 5 times a day. On the Day 0, day of the surgery, the patient will be instilled 1 drop of Moxifloxacin in the eye which will be operated prior to surgery and 1 drop twice post surgery. From Day 1 post surgery, patient will have 1 drop of Moxifloxacin instilled three times a day up to Day 14 (14 days after surgery). If there are any signs and symptoms of endophthalmitis, then at the investigator's discretion, Gram Stain & Culture assessment of aqueous & vitreous fluid may be performed post surgery on Days 1, 7, and 14.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients > 18 years of age, who have been prescribed 0.5% Moxifloxacin drops preoperatively 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
- •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
Post-op endophthalmitis rate up to Day 14
时间窗: Up to Day 14 after surgery
The post-op endophthalmitis rate = (No of patients in whom endophthalmitis occurred in post-op period up to Day 14/ no of enrolled patients) X 100
次要结局
- Number of patients with diagnosis of suspected endophthalmitis using microbiological culture and Gram stain of aqueous and vitreous fluids(Day 1, Day 7, Day 14 after surgery)
- Number and proportion of patients with ocular adverse events (AEs) after surgery(Up to Day 16 after surgery)
- Number of patients assessed for infection using 4 clinical signs post-surgery(Day 1, Day 7, Day 14 after surgery)