Clermont-Ferrand, 63000, France
Completed
NCT Number: NCT01155999
Clinical Efficacy and Safety of T1225 Versus Tobramycin 0.3 % Eye Drops in the Treatment of Purulent Bacterial Conjunctivitis of Children.
Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis of children.
Completed
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Notify MeKey information
Conditions
Age range
1 day–18 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Age ≥ one day of life and ≤ 18 years
- Purulent bacterial conjunctivitis
Treatment and study plan
T1225
Drugone drop twice daily (morning and evening) in each eye from Day 0 to Day 2
Tobramycin
Drug1 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
Primary outcomes
-
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).
Sponsors and collaborators
Lead sponsor
Laboratoires Thea
Industry
Registry information
Important dates
- Study start
- 2008
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Jul 2, 2010
- Registry last updated
- Oct 29, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.