An International, Multicenter, Randomized, Blinded-assessor, Parallel-group Clinical Study Comparing Eye Drops of Combined LEvofloxAcin + DExamethasone foR 7 Days Followed by Dexamethasone Alone for an Additional 7 Days vs. Tobramycin + Dexamethasone for 14 Days for the Prevention and Treatment of Inflammation and Prevention of Infection Associated With Cataract Surgery in Adults - LEADER 7
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- NTC srl
- 入组人数
- 808
- 试验地点
- 57
- 主要终点
- Number of Participants Without Signs of Anterior Chamber Inflammation
研究概览
简要总结
The purpose of this study is to demonstrate the non-inferiority of the study treatment (combined levofloxacin + dexamethasone eye drops) followed by dexamethasone eye drops alone vs. standard treatment in the prevention and treatment of postoperative ocular inflammation and prevention of infection.
详细描述
In clinical practice, topical treatment following cataract surgery is frequently administered using a combination between an antibiotic and a corticosteroid to promote patient adherence to therapy and to obtain both prevention of infection and treatment of post-surgical inflammation.
The combination of tobramycin and dexamethasone is among the most widely used combinations, however, treatment duration and the need for tapering posology over several weeks may favour the development of bacterial resistance. The study treatment associating a broad-spectrum antibiotic with a highly effective corticosteroid that can be used for a short period of time (one week) is therefore of considerable interest.
The aim of this study is to evaluate the non-inferiority of the study treatment, used for a limited period of time and followed by dexamethasone alone, compared to standard treatment in preventing and treating ocular inflammation and in preventing post-operative infection while limiting the emergence of antibiotic resistance.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Ocular conditions that at the discretion of the Investigator may interfere with the efficacy and/or safety evaluations
- •Patients undergoing bilateral cataract surgery
- •Patients under treatment with prostaglandin analogues or intravitreal injections of anti-vascular endothelial growth factor (VEGF) drugs
- •Systemic diseases that may interfere with the results of the study
- •Any condition that could interfere with correct instillation of eye drops
- •Ocular surgery in the study eye (including laser surgery) in the 3 months before screening
- •Monocular patients
- •Visual Acuity < 20/80 of the contralateral eye measured as ETDRS or Snellen
- •Contraindications to ocular treatment with Tobradex®, Maxidex® or levofloxacin/dexamethasone
- •Hypersensitivity to the study product or its excipients
- •Participation in other clinical studies within at least 5 half-lives of the Investigational Medicinal Product (IMP) used in the previous studies
- •Pregnancy or breastfeeding
研究组 & 干预措施
Levofloxacin + Dexamethasone followed by dexamethasone
Levofloxacin 5 mg/ml+Dexamethasone 1 mg/ml (7 days,1 drop/4 times a day) followed by dexamethasone 1 mg/ml (7 days,1 drop/4 times a day).
干预措施: Levofloxacin + dexamethasone followed by dexamethasone (Drug)
Tobramycin + dexamethasone
Tobramycin + dexamethasone (14 days, 1 drop/4 times a day).
干预措施: Tobramycin + Dexamethasone (Drug)
结局指标
主要结局
Number of Participants Without Signs of Anterior Chamber Inflammation
时间窗: Day 15
The number of participants without signs of anterior chamber inflammation (sum of cells and flare score = 0). The following non-inferiority hypotheses has been tested: H0 : πT - πS ≤ - Δ; H1 : πT - πS \> - Δ. Where πT and πS are the number of participants without signs of anterior chamber inflammation in the test and standard treatments, respectively, and the non-inferiority margin is Δ = 10%.
次要结局
- Number of Participants Without Signs of Anterior Ocular Chamber Inflammation(Day 0 (screening), 4, 8)
- Number of Participants With Endophthalmitis(Day 4, 8, 15)
- Total Ocular Symptoms Score (TOSS)(Day 4, 8, 15)
- Ocular Pain/Discomfort: 4-point Scale(Day 4, 8, 15)
- Use of Rescue Therapy(During all the treatment until day 15)
- Conjunctival Hyperemia(Day 4, 8, 15)