Efficacy and Safety of 2 Dosing Regimens of T1225 Eye Drops 1.5% Versus Oral Azithromycin in Treatment of Trachoma
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Trachoma |
Drug: Azithromycin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
- 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
- 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
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | May 2004 |
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.
Eligibility| Ages Eligible for Study: | 1 Year to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00356720 History of Changes |
| Other Study ID Numbers: | LT1225-PIII-10/03 |
| Study First Received: | July 25, 2006 |
| Last Updated: | July 25, 2006 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Trachoma Conjunctivitis, Bacterial Eye Infections, Bacterial Bacterial Infections Chlamydia Infections Chlamydiaceae Infections Gram-Negative Bacterial Infections Eye Infections Infection |
Conjunctivitis Conjunctival Diseases Eye Diseases Corneal Diseases Azithromycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013