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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.
Sponsor:
Information provided by (Responsible Party):
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT01155999
First received: June 30, 2010
Last updated: October 24, 2014
Last verified: September 2011

June 30, 2010
October 24, 2014
December 2008
February 2011   (final data collection date for primary outcome measure)
The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3 [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
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).
Clinical cure [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
  • a score 0 for bulbar conjunctival injection
  • a score 0 for conjunctival discharge
Complete list of historical versions of study NCT01155999 on ClinicalTrials.gov Archive Site
Not Provided
  • Clinical efficacy criteria [ Time Frame: Day 3 and day 7 ] [ Designated as safety issue: Yes ]
    • Day 3:

      • clinical improvement for the worse eye
      • clinical status

        • for the "other eye"
        • for "both eyes"
    • Day 7:

      • 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
Not Provided
Not Provided
 
Clinical Efficacy and Safety of T1225 Versus Tobramycin 0.3 % Eye Drops in the Treatment of Purulent Bacterial Conjunctivitis of Children.
Not Provided

Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis of children.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Purulent Bacterial Conjunctivitis
  • Drug: T1225
    one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
  • Drug: 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
  • Experimental: T1225
    Intervention: Drug: T1225
  • Active Comparator: Tobramycin
    Intervention: Drug: Tobramycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
286
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥ one day of life and ≤ 18 years
  • Purulent bacterial conjunctivitis
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01155999
LT1225-PIIIB-02/08, 2008-003567-39
Not Provided
Laboratoires Thea
Laboratoires Thea
Not Provided
Not Provided
Laboratoires Thea
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP