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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.

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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
Information provided by (Responsible Party):
Laboratoires Thea

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

Condition or disease Intervention/treatment Phase
Purulent Bacterial Conjunctivitis Drug: T1225 Drug: Tobramycin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : December 2008
Primary Completion Date : February 2011
Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Pinkeye
U.S. FDA Resources

Arm Intervention/treatment
Experimental: T1225 Drug: T1225
one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
Active Comparator: Tobramycin 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

Primary Outcome Measures :
  1. 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).

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥ one day of life and ≤ 18 years
  • Purulent bacterial conjunctivitis

Information from the National Library of Medicine

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
Sponsors and Collaborators
Laboratoires Thea

Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT01155999     History of Changes
Other Study ID Numbers: LT1225-PIIIB-02/08
2008-003567-39 ( EudraCT Number )
First Posted: July 2, 2010    Key Record Dates
Results First Posted: October 29, 2014
Last Update Posted: October 29, 2014
Last Verified: September 2011

Additional relevant MeSH terms:
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Anti-Bacterial Agents
Anti-Infective Agents