Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers

Phase 1

Completed

• Conditions: Eye Infections, Bacterial

• Registration Number: NCT00356772
• Lead Sponsor: Laboratoires Thea

Brief 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

Detailed Description

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.

Study Timeline

• Study Start: 2003-02
• Study Completion: 2003-03
• Status Verified: 2006-07
• Study First Submitted: 2006-07-25
• Study First Submitted QC: 2006-07-25
• Last Update Submitted: 2006-07-25
• Study First Posted: 2006-07-26
• Last Update Posted: 2006-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Azithromycin Ocular Conjunctiva Concentrations on Days 7 and 14.
Azithromycin Tear Concentrations on Day 7.

Secondary Outcome Measures

Name	Time	Method
Tolerance