Trial | NCT00357292  Report issue

Title

Ocular Tolerance, Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1.0, 1.5% in 48 Healthy Volunteers
Comparison of the Ocular Tolerance, the Safety and the Ocular Pharmacokinetics After One Drop of Three Different Concentrations of T1225 (0.5% - 1.0% - 1.5%) in 48 Healthy Volunteers

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    azithromycin ...

  • Study Participants

    None
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
The aim of the present study was to compare the ocular tolerance, safety and the ocular pharmacokinetics after a single administration of T1225 eye drops (0.5%, 1.0%, or 1.5%) in healthy volunteers.
Study Started
Mar 31
2002
Study Completion
Apr 30
2002
Last Update
Jul 27
2006
Estimate

Drug Azithromycin (T1225)

Criteria 

Inclusion Criteria:

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 +).

Exclusion Criteria:

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).
No Results Posted