Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers|
- Ocular pharmacokinetic in tears
|Study Start Date:||October 2002|
|Estimated Study Completion Date:||October 2002|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00357383
|Principal Investigator:||Didier CHASSARD, Dr||ASTER, Paris, France|