NCT00356850

Brief Summary

To evaluate azithromycin tear concentrations after instillation of one drop of one of the three T1225 concentrations (0.5%, 1% and 1.5%) and to evaluate the ocular safety.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started May 2002

Shorter than P25 for phase_1

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, 2002

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2002

Completed
4.2 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

Eye Infections, Bacterial

Outcome Measures

Primary Outcomes (4)

  • Area Under the Curve from 0 to 24 hours (AUC0-24h)

  • Elimination half-life (t1/2)

  • Maximum Concentration (Cmax)

  • Concentration 24 hours after instillation (C24h)

Secondary Outcomes (1)

  • Tolerance

Interventions

AzithromycinDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male/female aged from 18 to 45 years;
  • Written informed consent;
  • Healthy volunteers without any subjective ocular symptom;
  • Corrected visual acuity \>= 6/10;
  • Registered in the national register of healthy volunteers

You may not qualify if:

  • Ocular trauma, infection or inflammation within the last 3 months;
  • Conjunctival hyperaemia (score \>= 2);
  • Folliculo-papillary conjunctivitis (score \>= 2);
  • Topical ocular treatment within the last month;
  • Ocular surgery, including LASIK and PRK, within the last 12 months;
  • Other ocular laser within the last 3 months;
  • Zithromax® and Azadose® within the last 3 months;
  • Medication during the study (except: paracetamol, contraceptives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Eye Infections, Bacterial

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsEye InfectionsEye Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Claude DUBRAY, Professor

    Centre de Pharmacologie Clinique - Clermont-Ferrand (France)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
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

May 1, 2002

Study Completion

June 1, 2002

Last Updated

July 26, 2006

Record last verified: 2006-07