NCT00356720

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2004

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2006

Completed
Last Updated

July 26, 2006

Status Verified

July 1, 2006

First QC Date

July 25, 2006

Last Update Submit

July 25, 2006

Conditions

Trachoma

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (7)

  • Cure at Days 30 and 60,

  • cure in both eyes,

  • trachoma grades at each visit;

  • microbiological cure;

  • Ocular signs (bulbar conjunctival hyperaemia, discharge; lachrymation;

  • +2 more secondary outcomes

Interventions

AzithromycinDRUG

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Trachoma

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Conjunctivitis, BacterialEye Infections, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsChlamydia InfectionsChlamydiaceae InfectionsGram-Negative Bacterial InfectionsEye InfectionsConjunctivitisConjunctival DiseasesEye DiseasesCorneal Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Isabelle COCHEREAU, Professor

    CHU d'Angers, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 25, 2006

First Posted

July 26, 2006

Study Start

January 1, 2004

Study Completion

May 1, 2004

Last Updated

July 26, 2006

Record last verified: 2006-07