Aqueous Humour Concentrations After Topical apPlication of combinEd Levofloxacin-dexamethasone Eye dRops and of Its Single Components: a randoMized, assEssor-blinded, Parallel-group Study in Patients Undergoing Cataract Surgery - iPERME
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- NTC srl
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Aqueous Humour Concentration of Dexamethasone 21-phosphate
研究概览
简要总结
The purpose of this study is to evaluate the penetration of levofloxacin and dexamethasone 21-phosphate into the aqueous humour after ocular administration in combination or as single active ingredients.
详细描述
In most cases, postoperative care after cataract surgery consists of antiinflammatory and antibacterial drug therapy. The use of an ophthalmic solution containing the combination of a steroid and an antibiotic is routinely used in clinical practice; however, treatment duration could favour the emergence of antibiotic 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 measure the concentrations of levofloxacin and dexamethasone in the aqueous humour after topical application of the combined ophthalmic solution and its single components.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single
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
- •Written informed consent
- •Male or female patients, aged ≥40 years
- •Patient undergoing phacoemulsification
- •Corneal thickness between 450 μm and 600 μm as measured by means of pachymetry
- •Corneal integrity confirmed by means of fluorescein test
- •Adequate pupil dilation assessed at screening
- •Female patients of childbearing potential must have a negative pregnancy test
- •Ability to fully understand all study procedures
排除标准
- •Corneal epithelium integrity not confirmed by fluorescein test
- •History of corneal disease or dystrophy
- •History of ocular trauma with corneal damage
- •History of acute ocular inflammation (including uveitis) in the 6 months prior to screening
- •Previous ocular surgery (including laser treatment)
- •Treatment with an ophthalmic investigational drug in the 3 months prior to screening
- •Treatment with any topical ocular drug within 12 hours before start of cataract surgery other than study drugs and instillation of topical anaesthetic within 10 minutes before start of surgery
- •Treatment with any topical steroid or antibiotic drug in the 7 days prior to cataract surgery
- •Treatment with any systemic steroid or antibiotic drug in the 7 days prior to cataract surgery
- •Known hypersensitivity to levofloxacin, other fluoroquinolones or dexamethasone
- •Pregnant or lactating women
- •Patients who have received any investigational drug during the preceding 30 days or 5 times the plasma half-life, or who have previously participated in this trial
研究组 & 干预措施
Levofloxacin + Dexamethasone
Levofloxacin 5 mg/ml + Dexamethasone 1 mg/ml (30 μl administered twice before Limbal paracentesis).
Limbal paracentesis will be performed prior to cataract surgery.
干预措施: Levofloxacin + Dexamethasone (Drug)
Levofloxacin
Levofloxacin 5 mg/ml (30 μl administered twice before Limbal paracentesis).
Limbal paracentesis will be performed prior to cataract surgery.
干预措施: Levofloxacin (Drug)
Dexamethasone
Dexamethasone 1.14 mg/ml (26 μl administered twice before Limbal paracentesis).
Limbal paracentesis will be performed prior to cataract surgery.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Aqueous Humour Concentration of Dexamethasone 21-phosphate
时间窗: 90±15 min after the first administration of the study treatments
Defined as the concentration of dexamethasone 21-phosphate into the aqueous humour in all the three arms: Levofloxacin + Dexamethasone, Dexamethasone and Levofloxacin. The concentration of dexamethasone 21-phosphate has been measured by LC tandem mass spectrometry.
Aqueous Humour Concentration of Levofloxacin
时间窗: 90±15 min after the first administration of the study treatments
Defined as the concentration of levofloxacin into the aqueous humour in all the three arms: Levofloxacin + Dexamethasone, Dexamethasone and Levofloxacin.The concentration of levofloxacin has been measured by LC tandem mass spectrometry.
Aqueous Humour Concentration of Dexamethasone
时间窗: 90±15 min after the first administration of the study treatments
Defined as the concentration of dexamethasone into the aqueous humour in all the three arms: Levofloxacin + Dexamethasone, Dexamethasone and Levofloxacin.The concentration of dexamethasone has been measured by LC tandem mass spectrometry.
次要结局
未报告次要终点