Status:
COMPLETED
Efficacy and Safety of 2 Dosing Regimens of T1225 Eye Drops 1.5% Versus Oral Azithromycin in Treatment of Trachoma
Lead Sponsor:
Laboratoires Thea
Conditions:
Trachoma
Eligibility:
All Genders
1-10 years
Phase:
PHASE3
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 act...
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 B...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2004
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00356720
Start Date
January 1 2004
End Date
May 1 2004
Last Update
July 26 2006
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