Clinical Efficacy and Safety of 2 Dosing Regimens of T1225 Eye Drops 1.5% (Instilled Twice Daily for 2 or 3 Days) Versus Oral Azithromycin in Treatment of Trachoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 主要终点
- Cure at end of study, i.e. TF0 grade on simplified WHO trachoma grading system < 5 follicles ≥ 0.5 mm diameter in upper tarsal conjunctiva) in the worse eye
研究概览
简要总结
To assess in children the efficacy and safety of 2 dosing regimens of T1225 1.5% eye drops, in comparison to a reference product, single-dose oral azithromycin (AZM) 20 mg/kg, for the treatment of active trachoma. Evaluation of clinical efficacy was primary (% of clinical cure at Day 60 in Per Protocol Set), microbiological evaluation was secondary
详细描述
The aim of the present study was to compare the efficacy of the dosing regimen which was demonstrated in pharmacokinetic studies to be the best candidate for trachoma treatment (T1225 1.5% eye drops BID for 3 days) with a shorter duration of treatment (T1225 1.5% eye drops BID for 2 days) and with a single oral administration of AZM (20 mg/kg) in patients suffering from active trachoma. The study was to be performed in approximately 600 children (aged 1 to 10 years) from Guinea Conakry and Pakistan.
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
- Double
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 1-10 years;
- •written informed consent by legally acceptable representative;
- •TF+ TI0 (trachomatous inflammation - follicular) or TF+TI+ (trachomatous inflammation - follicular and intense) on simplified World Health Organisation (WHO) grading system
排除标准
- •Trichiasis or corneal opacity;
- •palpebral deformation;
- •clinically significant ocular abnormality;
- •ocular infection;
- •organic amblyopia;
- •hypersensitivity to treatments' components;
- •immunosuppressive conditions;
- •systemic AZM or steroids;
- •topical ophthalmic antibiotics within 3 months;
- •other systemic antibiotics within 1 month;
- •topical (ocular, nasal, bronchial etc.) treatments within 1 week;
- •systemic non-steroidal anti-inflammatory drugs on day before Day 0
结局指标
主要结局
Cure at end of study, i.e. TF0 grade on simplified WHO trachoma grading system < 5 follicles ≥ 0.5 mm diameter in upper tarsal conjunctiva) in the worse eye
at the end of the study
次要结局
- Cure at Days 30 and 60,
- cure in both eyes,
- trachoma grades at each visit;
- microbiological cure;
- Ocular signs (bulbar conjunctival hyperaemia, discharge; lachrymation;
- Global efficacy assessment by investigator.
- Tolerance