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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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

Detailed Summary: The aim of the present study was to compare ocular tolerance and safety after repeated instillations of T1225 1% and 1.5% eye drops and vehicle and to assess the residual azithromycin concentrations in tear, ocular conjunctiva and plasma samples, approximately 12 hours after the last Investigational Medicinal Product instillation.
Sponsor: Laboratoires Thea

Current Primary Outcome: Ocular pharmacokinetic in tears

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: October 2002
Date Completion: October 2002
Last Updated: July 26, 2006
Last Verified: July 2006