Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers

• Status: Completed
• Trial end date: 2002-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the ocular tolerance of T1225 1% and 1.5% eye drops versus vehicle after one instillation twice-daily (morning and evening), in one eye, during 3 days (from Day 0 to Day 2).

To assess azithromycin tear, conjunctiva and plasmatic concentrations, after a 3-day treatment period

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

Details

• Lead Sponsor: Laboratoires Thea
• Treatments: Azithromycin; Ophthalmic Solutions

Criteria

Inclusion Criteria:

• Male or female aged from 18 to 45 years old;

• Written informed consent;

• Healthy volunteers without any subjective ocular symptom;

• Normal ocular examination in both eyes (corrected visual acuity >= 6/10, normal slit lamp examination, tear prism height > 0.1mm, tear break-up time (BUT) >= 10 seconds, lissamine green test score < 4);

• Registered, or agreed to be registered, in the national register of healthy volunteers

Exclusion Criteria:

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

• number of corneal stained punctuations Ocular trauma, infection or inflammation within the last 3 months;

• number of corneal stained punctuations >= 5;

• blepharitis, conjunctivitis, uveitis;

• contact lenses;

• topical ocular treatment within the last month;

• ocular laser within the last 3 months;

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

• systemic macrolide within the last month;

• medication during the study (except: paracetamol and contraceptives).