Clinical Trial: Efficacy and Safety of T1225 1.5% Versus Tobramycin 0.3 % in the Treatment of Purulent Bacterial Conjunctivitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Clinical Efficacy and Safety of T1225 1.5% Eye Drops (3-Day Treatment) Versus Tobramycin 0.3 % Eye Drops (7-Day Treatment) in the Treatment of Purulent Bacterial Conjunctivitis
Brief Summary: To demonstrate the efficacy of T1225 1.5% eye drops, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis, and to assess the safety
Detailed Summary: The aim of the present study was to compare the efficacy and safety of T1225 1.5% eye drops administered BID for 3 days in comparison to reference antibiotic eye drops, tobramycin, for the treatment of purulent bacterial conjunctivitis. The study was conducted as a Phase III, multicentre, international, investigator-masked, randomised, parallel-group, non-inferiority study in newborns, children, and adults.
Sponsor: Laboratoires Thea
Current Primary Outcome: Clinical cure in the worse eye on Test of Cure (TOC) visit at Day 9, defined as a score 0 for bulbar conjunctival injection and a score 0 for conjunctival purulent discharge (each graded on 4-point scales)
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Clinical cure at Day 3
- Microbiological cure at Day 3 and Day 9
- Global efficacy.
- Tolerance
Original Secondary Outcome: Same as current
Information By: Laboratoires Thea
Dates:
Date Received: July 25, 2006
Date Started: May 2004
Date Completion: June 2005
Last Updated: July 26, 2006
Last Verified: July 2006