drugset / Trial / NCT00356720
Efficacy and Safety of 2 Dosing Regimens of T1225 Eye Drops 1.5% Versus Oral Azithromycin in Treatment of Trachoma
RandomizedParallel-groupDouble-blindTreatment
Summary
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
Timeline
- Start
- 2004-01
- Primary completion
- —
- Completion
- 2004-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azithromycin | Small molecule | 20 mg/kg | Oral |