Clinical Efficacy and Safety of T1225 1.5% Eye Drops (3-Day Treatment) Versus Tobramycin 0.3 % Eye Drops (7-Day Treatment) in the Treatment of Purulent Bacterial Conjunctivitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 主要终点
- Clinical cure in the worse eye on Test of Cure (TOC) visit at Day 9, defined as a score 0 for bulbar conjunctival injection and a score 0 for conjunctival purulent discharge (each graded on 4-point scales)
研究概览
简要总结
To demonstrate the efficacy of T1225 1.5% eye drops, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis, and to assess the safety
详细描述
The aim of the present study was to compare the efficacy and safety of T1225 1.5% eye drops administered BID for 3 days in comparison to reference antibiotic eye drops, tobramycin, for the treatment of purulent bacterial conjunctivitis. The study was conducted as a Phase III, multicentre, international, investigator-masked, randomised, parallel-group, non-inferiority study in newborns, children, and adults.
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
- Single
入排标准
- 年龄范围
- 1 Day 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female >= 1 day old (newborn, infant, child, adult);
- •written informed consent by patient or legally acceptable representative;
- •purulent bacterial conjunctivitis (unilateral or bilateral) defined as bulbar conjunctival injection (mild, moderate, or severe) AND conjunctival purulent discharge (mild, moderate or severe).
排除标准
- •Bacterial conjunctivitis diagnosed >= 7 days ago;
- •bacterial infection due to trauma or foreign body;
- •dacryocystitis;
- •corneal ulceration or keratitis;
- •viral ocular infection; closed angle glaucoma;
- •acute allergy conjunctivitis;
- •clinically significant ocular abnormality;
- •organic amblyopia, monophthalmia;
- •corrected visual acuity below 20/100;
- •contact lens wearer;
- •newborn (i.e. 0-2 months old) not born at term (< 37 weeks of amenorrhea);
- •ocular surgery, laser in situ keratomileusis (LASIK), laser epithelial keratomileusis (LASEK), or photo-refractive keratectomy (PRK) in last 12 months;
- •ocular laser treatment in last 3 months;
- •systemic macrolide antibiotics in last month;
- •systemic steroids in last 2 weeks or during the study;
- •topical ocular macrolide antibiotics and/or topical ocular steroids and/or non-steroidal anti-inflammatory drugs (NSAIDs) in last week;
- •topical (ocular, nasal, bronchial etc.) treatments and/or systemic NSAIDs in last day;
- •immunosuppressives and/or any systemic antibiotic on D0.
结局指标
主要结局
Clinical cure in the worse eye on Test of Cure (TOC) visit at Day 9, defined as a score 0 for bulbar conjunctival injection and a score 0 for conjunctival purulent discharge (each graded on 4-point scales)
次要结局
- Clinical cure at Day 3
- Microbiological cure at Day 3 and Day 9
- Global efficacy.
- Tolerance