Clinical Efficacy and Safety of T1225 Versus Tobramycin 0.3 % Eye Drops in the Treatment of Purulent Bacterial Conjunctivitis of Children.
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|ClinicalTrials.gov Identifier: NCT01155999|
Recruitment Status : Completed
First Posted : July 2, 2010
Results First Posted : October 29, 2014
Last Update Posted : October 29, 2014
|Condition or disease||Intervention/treatment||Phase|
|Purulent Bacterial Conjunctivitis||Drug: T1225 Drug: Tobramycin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||286 participants|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
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
- The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3 [ Time Frame: Day 3 ]Clinical cure was defined as a score 0 for bulbar conjunctival injection (evaluated using a 4 point ordinal scale) and a score 0 for conjunctival purulent discharge (evaluated using a 4 point ordinal scale).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155999
|Clermont-Ferrand, France, 63000|