Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers

• Status: Completed
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate azithromycin ocular conjunctiva concentrations 7 and 14 days after treatment initiation.

To assess ocular and systemic tolerance/safety and azithromycin tear concentrations on Day 7

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

Details

• Lead Sponsor: Laboratoires Thea
• Treatments: Azithromycin

Criteria

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).