Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers

The aim of the present study was to compare azithromycin tear and conjunctival ocular concentrations after one instillation of T1225 1.5% eye drops, twice a day during one day versus one instillation of T1225 1.5% eye drops, twice a day during 3 days versus an oral single dose of 1g azithromycin.

Inclusion criteria

• Written informed consent;
• Healthy volunteers;
• Registered in the national register of healthy volunteers;
• Male or female aged from 18 to 45 years old;
• Able to understand the study instructions;
• Likely to comply with the study schedule and treatment;
• Normal subjective ocular symptoms, Schirmer test > 10 mm in 5 min and corrected visual acuity >= 6/10 in both eyes

Exclusion criteria

• Ocular trauma, infection or inflammation within the last 3 months;
• Blepharitis;
• Conjunctival hyperaemia (score >= 2);
• Fluorescein-stained punctuations (score >= 1b);
• Hypersensitivity to one of the products used in the study;
• Clinically relevant allergy;
• Medical or surgical history incompatible with the study;
• Recent acute illness;
• Ocular surgery, including LASIK, LASEK and PRK within the last 12 months;
• Other ocular lasers or Zithromax® or Azadose® within the last 3 months;
• Systemic antibiotics and ocular medications within the last month;
• Contact lenses within the last week;
• Any medication on Day 0 and during the study (except paracetamol and contraceptives).