Trachoma Clinical Trial
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
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
Status | Completed |
Enrollment | 0 |
Est. completion date | May 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 10 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Laboratoires Thea |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |||
Primary | at the end of the study | |||
Secondary | Cure at Days 30 and 60, | |||
Secondary | cure in both eyes, | |||
Secondary | trachoma grades at each visit; | |||
Secondary | microbiological cure; | |||
Secondary | Ocular signs (bulbar conjunctival hyperaemia, discharge; lachrymation; | |||
Secondary | Global efficacy assessment by investigator. | |||
Secondary | Tolerance |
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