Ocular Tolerance, Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1.0, 1.5% in 48 Healthy Volunteers

• Status: Completed
• Trial end date: 2002-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Laboratoires Thea
• Treatments: Azithromycin

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).