Efficacy and Safety of 2 Dosing Regimens of T1225 Eye Drops 1.5% Versus Oral Azithromycin in Treatment of Trachoma

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00356720
• Other study ID #: LT1225-PIII-10/03
• 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
• 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

• Trachoma

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