Brief Title
Efficacy and Safety of 2 Dosing Regimens of T1225 Eye Drops 1.5% Versus Oral Azithromycin in Treatment of Trachoma
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
Brief 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
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.
Study Phase
Phase 3
Study Type
Interventional
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
Secondary Outcome
Cure at Days 30 and 60,
Condition
Trachoma
Intervention
Azithromycin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Start Date
January 2004
Completion Date
May 2004
Eligibility 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
Gender
All
Ages
1 Year - 10 Years
Accepts Healthy Volunteers
No
Contacts
Isabelle COCHEREAU, Professor, ,
Administrative Informations
NCT ID
NCT00356720
Organization ID
LT1225-PIII-10/03
Study Sponsor
Laboratoires Thea
Study Sponsor
Isabelle COCHEREAU, Professor, Principal Investigator, CHU d'Angers, France
Verification Date
July 2006