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

Condition(s) targeted: Trachoma

Intervention: Azithromycin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Laboratoires Thea

Official(s) and/or principal investigator(s):
Isabelle COCHEREAU, Professor, Principal Investigator, Affiliation: CHU d'Angers, France

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

Official title: 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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study

Primary outcome:

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

Secondary outcome:

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

Detailed 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.

Minimum age: 1 Year. Maximum age: 10 Years. Gender(s): Both.

Criteria:

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:

- 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

Starting date: January 2004
Ending date: May 2004
Last updated: July 25, 2006