Ocular Pharmacokinetics After a Single Drop Instillation of T1225 0.5, 1, 1.5% in 91 Healthy Volunteers

• Status: Completed
• Trial end date: 2002-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate azithromycin tear concentrations after instillation of one drop of one of the three T1225 concentrations (0.5%, 1% and 1.5%) and to evaluate the ocular safety.

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

Details

• Lead Sponsor: Laboratoires Thea
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

• Male/female aged from 18 to 45 years;

• Written informed consent;

• Healthy volunteers without any subjective ocular symptom;

• Corrected visual acuity >= 6/10;

• Registered in the national register of healthy volunteers

Exclusion Criteria:

• Ocular trauma, infection or inflammation within the last 3 months;

• Conjunctival hyperaemia (score >= 2);

• Folliculo-papillary conjunctivitis (score >= 2);

• Topical ocular treatment within the last month;

• Ocular surgery, including LASIK and PRK, within the last 12 months;

• Other ocular laser within the last 3 months;

• Zithromax® and Azadose® within the last 3 months;

• Medication during the study (except: paracetamol, contraceptives