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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:
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT01155999
First received: June 30, 2010
Last updated: September 9, 2011
Last verified: September 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • Clinical cure [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
    • a score 0 for bulbar conjunctival injection
    • a score 0 for conjunctival discharge


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 222
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

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ one day of life and ≤ 18 years
  • Purulent bacterial conjunctivitis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01155999

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

No publications provided

Responsible Party: Medical Director, Laboratoires Théa
ClinicalTrials.gov Identifier: NCT01155999     History of Changes
Other Study ID Numbers: LT1225-PIIIB-02/08, 2008-003567-39
Study First Received: June 30, 2010
Last Updated: September 9, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Belgium: Federal Agency for Medicinal Products and Health Products
Portugal: National Pharmacy and Medicines Institute
Spain: Spanish Agency of Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Tunisia: Ministry of Public Health
Algeria: Ministry of Health
Italy: The Italian Medicines Agency

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013