NCT00357773

Brief Summary

To demonstrate the efficacy of T1225 1.5% eye drops, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis, and to assess the safety

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started May 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2006

Completed
Last Updated

July 27, 2006

Status Verified

July 1, 2006

First QC Date

July 25, 2006

Last Update Submit

July 26, 2006

Conditions

Conjunctivitis, Bacterial

Outcome Measures

Primary Outcomes (1)

  • Clinical cure in the worse eye on Test of Cure (TOC) visit at Day 9, defined as a score 0 for bulbar conjunctival injection and a score 0 for conjunctival purulent discharge (each graded on 4-point scales)

Secondary Outcomes (4)

  • Clinical cure at Day 3

  • Microbiological cure at Day 3 and Day 9

  • Global efficacy.

  • Tolerance

Interventions

Azithromycin (T1225)DRUG

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female \>= 1 day old (newborn, infant, child, adult);
  • written informed consent by patient or legally acceptable representative;
  • purulent bacterial conjunctivitis (unilateral or bilateral) defined as bulbar conjunctival injection (mild, moderate, or severe) AND conjunctival purulent discharge (mild, moderate or severe).

You may not qualify if:

  • Bacterial conjunctivitis diagnosed \>= 7 days ago;
  • bacterial infection due to trauma or foreign body;
  • dacryocystitis;
  • corneal ulceration or keratitis;
  • viral ocular infection; closed angle glaucoma;
  • acute allergy conjunctivitis;
  • clinically significant ocular abnormality;
  • organic amblyopia, monophthalmia;
  • corrected visual acuity below 20/100;
  • contact lens wearer;
  • newborn (i.e. 0-2 months old) not born at term (\< 37 weeks of amenorrhea);
  • ocular surgery, laser in situ keratomileusis (LASIK), laser epithelial keratomileusis (LASEK), or photo-refractive keratectomy (PRK) in last 12 months;
  • ocular laser treatment in last 3 months;
  • systemic macrolide antibiotics in last month;
  • systemic steroids in last 2 weeks or during the study;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Conjunctivitis, Bacterial

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Eye Infections, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsEye InfectionsConjunctivitisConjunctival DiseasesEye 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
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 25, 2006

First Posted

July 27, 2006

Study Start

May 1, 2004

Study Completion

June 1, 2005

Last Updated

July 27, 2006

Record last verified: 2006-07