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

• Status: Completed
• Trial end date: 2002-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the ocular tolerance, safety and ocular pharmacokinetics of 3 concentrations (0.5%

• 1.0% - 1.5%) and the vehicle of T1225.

• 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;

• 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).