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

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratoires Thea
• Treatments: Azithromycin; Ophthalmic Solutions

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