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

Thea Pharma

Status and phase

Completed

Phase 3

Conditions

Trachoma

Treatments

Drug: Azithromycin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00356720

LT1225-PIII-10/03

Details and patient eligibility

About

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

Full description

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.

Sex

All

Ages

1 to 10 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria