Clinical Trial: Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1 and 1.5% in 48 Healthy Volunteers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Comparison of the Ocular Tolerance, the Safety and the Ocular Pharmacokinetics After One Drop of Three Different Concentrations of T1225 (0.5% - 1.0% - 1.5%) in 48 Healthy Volunteers
Brief Summary: To compare the ocular tolerance, safety and ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225.
Detailed Summary: The present phase I clinical trial was performed in order to investigate the ocular tolerance, safety and the ocular pharmacokinetics of a single administration of T1225 eye drops (0.5%, 1.0%, or 1.5%) in healthy volunteers.
Sponsor: Laboratoires Thea
Current Primary Outcome:
- Subjective ocular symptoms
- Objective ocular symptoms
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Systemic adverse events
- Ocular adverse events
- Ocular pharmacokinetic
Original Secondary Outcome: Same as current
Information By: Laboratoires Thea
Dates:
Date Received: July 25, 2006
Date Started: February 2002
Date Completion: March 2002
Last Updated: July 26, 2006
Last Verified: July 2006
