Back to resultsClinical Efficacy and Safety of T1225 Versus Tobramycin 0.3 % Eye Drops in the Treatment of Purulent Bacterial Conjunctivitis of Children.
Primary Purpose
Purulent Bacterial Conjunctivitis
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
T1225
Tobramycin
Sponsored by
About this trial
This is an interventional treatment trial for Purulent Bacterial Conjunctivitis
Eligibility Criteria
Inclusion Criteria:
- Age ≥ one day of life and ≤ 18 years
- Purulent bacterial conjunctivitis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
T1225
Tobramycin
Arm Description
Outcomes
Primary Outcome Measures
The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on 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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01155999
Brief Title
Clinical Efficacy and Safety of T1225 Versus Tobramycin 0.3 % Eye Drops in the Treatment of Purulent Bacterial Conjunctivitis of Children.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires Thea
4. Oversight
5. Study Description
Brief Summary
Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis of children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Purulent Bacterial Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
286 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T1225
Arm Type
Experimental
Arm Title
Tobramycin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
T1225
Intervention Description
one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
Intervention Type
Drug
Intervention Name(s)
Tobramycin
Intervention Description
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 Measure Information:
Title
The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ one day of life and ≤ 18 years
Purulent bacterial conjunctivitis
Facility Information:
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
12. IPD Sharing Statement
Learn more about this trial
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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