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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00356720
Other study ID # LT1225-PIII-10/03
Secondary ID
Status Completed
Phase Phase 3
First received July 25, 2006
Last updated July 25, 2006
Start date January 2004
Est. completion date May 2004

Study information

Verified date July 2006
Source Laboratoires Thea
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Azithromycin


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Laboratoires Thea

Outcome

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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