drugset / Trial / NCT00356720

Efficacy and Safety of 2 Dosing Regimens of T1225 Eye Drops 1.5% Versus Oral Azithromycin in Treatment of Trachoma

NCT00356720

Phase 3 Completed Laboratoires Thea
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

EvaluationDrugModalityDoseRoute
Subject Azithromycin Small molecule 20 mg/kg Oral

Indications