Clinical Efficacy and Safety of T1225 Versus Tobramycin 0.3 % Eye Drops in the Treatment of Purulent Bacterial Conjunctivitis of Children.
This study has been completed.
Information provided by:
First received: June 30, 2010
Last updated: September 9, 2011
Last verified: September 2011
Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis of children.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Laboratoires Thea:
Primary Outcome Measures:
- Clinical cure [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
- a score 0 for bulbar conjunctival injection
- a score 0 for conjunctival discharge
Secondary Outcome Measures:
- Clinical efficacy criteria [ Time Frame: Day 3 and day 7 ] [ Designated as safety issue: Yes ]
- clinical improvement for the worse eye
- for the "other eye"
- for "both eyes"
- clinical status for the "worse eye"
- clinical status for the "other eye"
- clinical status for "both eyes"
- Bacteriological efficacy [ Time Frame: Day 0 and Day 7 ] [ Designated as safety issue: Yes ]Bacterial outcome
|Study Start Date:||December 2008|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
|Active Comparator: Tobramycin||
1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
Contacts and Locations