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

NCT00356720 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2006-07-26

No results posted yet for this study

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

Conditions

  • Trachoma

Interventions

DRUG

Azithromycin

Sponsors & Collaborators

  • Laboratoires Thea

    lead INDUSTRY

Principal Investigators

  • Isabelle COCHEREAU, Professor · CHU d'Angers, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Completion
2004-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00356720 on ClinicalTrials.gov