NCT00357539

Brief Summary

To compare the ocular tolerance, safety and ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Feb 2002

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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, 2002

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
4.4 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

Eye Infections, Bacterial

Outcome Measures

Primary Outcomes (2)

  • Subjective ocular symptoms

  • Objective ocular symptoms

Secondary Outcomes (3)

  • Systemic adverse events

  • Ocular adverse events

  • Ocular pharmacokinetic

Interventions

Azithromycin (T1225)DRUG

Eligibility Criteria

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

You may qualify if:

  • Male or female aged from 18 to 45 years old;
  • Written informed consent;
  • Healthy volunteers (without any ocular symptom);
  • Normal ocular examination in both eyes (corrected visual acuity (VA) \>= 6/10 - slit lamp examination without clinical relevant abnormalities - tear break-up time (BUT) \>= 10 seconds - lachrymal secretion in the Schirmer test \>= 10 mm in 5 minutes - lissamine green test total score \< 4).

You may not qualify if:

  • Ocular trauma, infection or inflammation within the last 3 months;
  • Conjunctival hyperaemia score \>= 2, watering score \>= 2, folliculo-papillary conjunctivitis score \>= 2, number of fluorescein-stained punctuations \>= 10;
  • Blepharitis, conjunctivitis, uveitis;
  • Ocular laser treatment within the last 3 months;
  • Ocular surgery, including LASIK and PRK, within the last 12 months;
  • Topical ocular treatment during the last month;
  • Ocular antibiotics within the last 7 days;
  • Medication during the study (except paracetamol and contraceptives).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité de Pharmacologie Clinique

Clermont-Ferrand, 63009, France

Location

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

    Unité 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 27, 2006

Study Start

February 1, 2002

Study Completion

March 1, 2002

Last Updated

July 27, 2006

Record last verified: 2006-07

Locations

FR(1)