NCT00356772

Brief Summary

To evaluate azithromycin ocular conjunctiva concentrations 7 and 14 days after treatment initiation. To assess ocular and systemic tolerance/safety and azithromycin tear concentrations on Day 7

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Feb 2003

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

February 1, 2003

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
3.4 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 (2)

  • Azithromycin Ocular Conjunctiva Concentrations on Days 7 and 14.

  • Azithromycin Tear Concentrations on Day 7.

Secondary Outcomes (1)

  • Tolerance

Interventions

AzithromycinDRUG

Eligibility Criteria

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

You may qualify if:

  • Written informed consent;
  • Healthy volunteers;
  • Registered in the national register of healthy volunteers;
  • Male or female aged from 18 to 45 years old;
  • Able to understand the study instructions;
  • Likely to comply with the study schedule and treatment;
  • Normal subjective ocular symptoms, Schirmer test \> 10 mm in 5 min and corrected visual acuity \>= 6/10 in both eyes

You may not qualify if:

  • Ocular trauma, infection or inflammation within the last 3 months;
  • Blepharitis;
  • Conjunctival hyperaemia (score \>= 2);
  • Fluorescein-stained punctuations (score \>= 1b);
  • Hypersensitivity to one of the products used in the study;
  • Clinically relevant allergy;
  • Medical or surgical history incompatible with the study;
  • Recent acute illness;
  • Ocular surgery, including LASIK, LASEK and PRK within the last 12 months;
  • Other ocular lasers or Zithromax® or Azadose® within the last 3 months;
  • Systemic antibiotics and ocular medications within the last month;
  • Contact lenses within the last week;
  • Any medication on Day 0 and during the study (except paracetamol and 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
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 25, 2006

First Posted

July 26, 2006

Study Start

February 1, 2003

Study Completion

March 1, 2003

Last Updated

July 26, 2006

Record last verified: 2006-07