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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
Results First Received: October 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Purulent Bacterial Conjunctivitis
Interventions: Drug: T1225
Drug: Tobramycin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
T1225 T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
Tobramycin 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

Participant Flow:   Overall Study
    T1225   Tobramycin
STARTED   146   140 
COMPLETED   139   136 
NOT COMPLETED   7   4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
T1225 T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
Tobramycin 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
Total Total of all reporting groups

Baseline Measures
   T1225   Tobramycin   Total 
Overall Participants Analyzed 
[Units: Participants]
 146   136   282 
Age 
[Units: Years]
Mean (Standard Deviation)
 3.06  (3.40)   3.52  (4.17)   3.28  (3.79) 
Gender 
[Units: Participants]
     
Female   76   68   144 
Male   70   68   138 
Region of Enrollment 
[Units: Participants]
     
France   15   11   26 
Germany   14   11   25 
Italy   2   2   4 
Poland   19   17   36 
Portugal   2   4   6 
Romania   29   28   57 
Algeria   18   17   35 
Tunisia   47   46   93 


  Outcome Measures

1.  Primary:   The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3   [ Time Frame: Day 3 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pascale Pouliquen (Medical director)
Organization: Laboratoires Thea
phone: 0473963614
e-mail: p.pouliquen@laboratoires-thea.fr



Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT01155999     History of Changes
Other Study ID Numbers: LT1225-PIIIB-02/08
2008-003567-39 ( EudraCT Number )
Study First Received: June 30, 2010
Results First Received: October 24, 2014
Last Updated: October 24, 2014
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