NCT00357292

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Mar 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

March 1, 2002

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2002

Completed
4.3 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)

  • Ocular subjective symptoms

  • Ocular objective symptoms

Secondary Outcomes (2)

  • Ocular pharmacokinetic.

  • Ocular and systemic adverse events.

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;
  • Blepharitis;
  • Conjunctival hyperaemia (score \>= 2 +);
  • Watering (score \>= 2);
  • Contact lenses;
  • Ocular surgery, including LASIK and PRK, within the last 12 months;
  • Topical ocular treatment within the last month;
  • Systemic antibiotics within the last 7 days;
  • Any medication 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

  • Khalid TABBARA, Professor

    The Eye Center, Riyadh (Saudi Arabia)

    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

March 1, 2002

Study Completion

April 1, 2002

Last Updated

July 27, 2006

Record last verified: 2006-07