NCT00357383

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Laboratoires Thea · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Eye Infections, Bacterial

Interventions

Type	Name	Description
DRUG	Azithromycin (T1225)

Timeline

• Start date: 2002-10-01
• Completion: 2002-10-01
• First posted: 2006-07-27
• Last updated: 2006-07-27