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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:
ClinicalTrials.gov Identifier:
NCT01155999
First Posted: July 2, 2010
Last Update Posted: October 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Laboratoires Thea
  Purpose
Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis of children.

Condition Intervention Phase
Purulent Bacterial Conjunctivitis Drug: T1225 Drug: Tobramycin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • 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).


Enrollment: 286
Study Start Date: December 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

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


Locations
France
Clermont-Ferrand, France, 63000
Sponsors and Collaborators
Laboratoires Thea
  More Information

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 Submitted: June 30, 2010
First Posted: July 2, 2010
Results First Submitted: October 24, 2014
Results First Posted: October 29, 2014
Last Update Posted: October 29, 2014
Last Verified: September 2011

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