Double-Masked, Randomized, Parallel Group Study for Evaluation of Non-Inferiority of 0.3%Gatifloxacin/1.0% Prednisolone Association Compared With Their Isolated Administration in the Prevention of Ocular Infection/Inflammation After LASIK Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Percentage of eyes with absence of signs/symptoms of ocular infection/inflammation after surgery.
研究概览
简要总结
The purpose of the study is to evaluate the safety and tolerance of the 0.3% gatifloxacin and 1.0% prednisolone acetate association in eye drops in the prevention of infection and inflammation after refractive surgery (Lasik) and also demonstrate the non-inferiority of the efficacy of this association compared to the administration of 0.3% gatifloxacin and 1.0% prednisolone acetate as isolated eye drops formulations. The study treatment is randomized, double-masked, with 2 parallel arms. Each patient's participation lasts 29 days, with 15 days of study treatment administration after the ocular surgery is performed. Candidates for the study are patients with indication for ocular refractive surgery (Lasik) for correction of visual acuity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient is indicated to have an ocular refractive surgery performed (myopia, astigmatism, hypermetropy) by the Lasik method.
- •Patient presents a normal eye fundus.
- •Patient has intraocular pressure (IOP) ≤ 20 mmHg.
排除标准
- •Surgery and/or previous ocular pathology (presence of scar/change in the cornea, glaucoma, retinopathies, etc.).
- •Patient has diabetes or is immunodepressed.
- •Any systemic infection during the study.
- •Signs and/or symptoms of ocular inflammation/infection (bacterial, viral, fungal, caused by Chlamydia, by Mycobacterium, Acanthamoeba or of allergic etiology).
- •Have used any systemic or topical antibiotics for ocular infection in the previous 14 days.
- •Patient has known hypersensitivity to any of the components of the formulations used in the study.
研究组 & 干预措施
Association
0.3% gatifloxacin and 1.0% prednisolone acetate association in eye drops plus placebo
干预措施: 0.3% gatifloxacin and 1.0% prednisolone acetate association (Drug)
Isolated ingredients
0.3% gatifloxacin and 1.0% prednisolone acetate isolated eye drops formulations
干预措施: isolated 0.3% gatifloxacin and 1.0% prednisolone acetate (Drug)
结局指标
主要结局
Percentage of eyes with absence of signs/symptoms of ocular infection/inflammation after surgery.
时间窗: Day 15
次要结局
未报告次要终点