Clinical Trial: Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Comparison of Azithromycin Level in Tears and in Conjunctiva After Repeated Instillations of T1225 1.5% Eye Drops or After a Single Per Os Administration of Zithromax® (Azithromycin 1g), in 36 He
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 Summary: 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.
Sponsor: Laboratoires Thea
Current Primary Outcome:
- Azithromycin Ocular Conjunctiva Concentrations on Days 7 and 14.
- Azithromycin Tear Concentrations on Day 7.
Original Primary Outcome: Same as current
Current Secondary Outcome: Tolerance
Original Secondary Outcome: Same as current
Information By: Laboratoires Thea
Dates:
Date Received: July 25, 2006
Date Started: February 2003
Date Completion: March 2003
Last Updated: July 25, 2006
Last Verified: July 2006
