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Trial record 5 of 26 for:    "Bacterial Conjunctivitis" | "Anti-Bacterial Agents"

Clinical Efficacy and Safety of T1225 Versus Tobramycin 0.3 % Eye Drops in the Treatment of Purulent Bacterial Conjunctivitis of Children.

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.
 
ClinicalTrials.gov Identifier: NCT01155999
Recruitment Status : Completed
First Posted : July 2, 2010
Results First Posted : October 29, 2014
Last Update Posted : October 29, 2014
Sponsor:
Information provided by (Responsible Party):
Laboratoires Thea

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Purulent Bacterial Conjunctivitis
Interventions Drug: T1225
Drug: Tobramycin
Enrollment 286
Recruitment Details  
Pre-assignment Details  
Arm/Group Title T1225 Tobramycin
Hide Arm/Group Description T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2 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
Period Title: Overall Study
Started 146 140
Completed 139 136
Not Completed 7 4
Arm/Group Title T1225 Tobramycin Total
Hide Arm/Group Description T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2 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 of all reporting groups
Overall Number of Baseline Participants 146 136 282
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 146 participants 136 participants 282 participants
3.06  (3.40) 3.52  (4.17) 3.28  (3.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants 136 participants 282 participants
Female
76
  52.1%
68
  50.0%
144
  51.1%
Male
70
  47.9%
68
  50.0%
138
  48.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 146 participants 136 participants 282 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
1.Primary Outcome
Title The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3
Hide Description 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).
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis of the primary clinical efficacy variable was primarily performed on the basis of the MFAS. The MFAS consisted of all patients of the FAS with positive Day 0 culture results in an eligible eye.
Arm/Group Title T1225 Tobramycin
Hide Arm/Group Description:
T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
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
Overall Number of Participants Analyzed 102 101
Measure Type: Number
Unit of Measure: participants
48 29
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title T1225 Tobramycin
Hide Arm/Group Description T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2 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
All-Cause Mortality
T1225 Tobramycin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
T1225 Tobramycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/146 (0.00%)   0/140 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
T1225 Tobramycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/146 (0.00%)   0/140 (0.00%) 
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.
All the results of the Trial are the sole and exclusive property of THEA, and cannot be used in whatever form without prior written agreement of THEA.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pascale Pouliquen (Medical director)
Organization: Laboratoires Thea
Phone: 0473963614
EMail: p.pouliquen@laboratoires-thea.fr
Layout table for additonal 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