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.