Back to resultsTOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension
Primary Purpose
Ocular Inflammation Associated With Blepharaconjunctivitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tobramycin 0.3%/Dexamethasone 0.05%
TOBRADEX
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Inflammation Associated With Blepharaconjunctivitis focused on measuring Ocular inflammation, blepharaconjunctivitis
Eligibility Criteria
Inclusion Criteria:
- Ocular inflammation associated with blepharaconjunctivitis
Exclusion Criteria:
- ocular allergy
- ocular disorders that would preclude safe administration of test article
Sites / Locations
- Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tobramycin 0.3%/Dexamethasone 0.05%
TOBRADEX
Arm Description
Tobramycin 0.3%/Dexamethasone 0.05% 1 drop 4 times daily in both eyes
TOBRADEX 1 drop 4 times daily in both eyes
Outcomes
Primary Outcome Measures
Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4)
Microbiological success was declared if the pre-therapy pathogens were eradicated at the Exit Visit; conversely, microbiological failure was declared if pre-therapy pathogens persisted at the exit visit. The microbiological outcomes were calculated based on an algorithm that assessed whether pre-therapy pathogens were eradicated or persisted as demonstrated by comparative characterization of recovered bacteria.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00576251
Brief Title
TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
March 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to describe the differences in efficacy between TOBRADEX Ophthalmic Suspension and Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension in the treatment of ocular inflammation and infection associated with blepharaconjunctivitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Inflammation Associated With Blepharaconjunctivitis
Keywords
Ocular inflammation, blepharaconjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
221 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tobramycin 0.3%/Dexamethasone 0.05%
Arm Type
Experimental
Arm Description
Tobramycin 0.3%/Dexamethasone 0.05% 1 drop 4 times daily in both eyes
Arm Title
TOBRADEX
Arm Type
Active Comparator
Arm Description
TOBRADEX 1 drop 4 times daily in both eyes
Intervention Type
Drug
Intervention Name(s)
Tobramycin 0.3%/Dexamethasone 0.05%
Intervention Description
Tobramycin 0.3%/Dexamethasone 0.05% 1 drop in both eyes 4 times daily for at least 3 days
Intervention Type
Drug
Intervention Name(s)
TOBRADEX
Intervention Description
TOBRADEX 1 drop in both eyes 4 times daily for at least 3 days
Primary Outcome Measure Information:
Title
Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4)
Description
Microbiological success was declared if the pre-therapy pathogens were eradicated at the Exit Visit; conversely, microbiological failure was declared if pre-therapy pathogens persisted at the exit visit. The microbiological outcomes were calculated based on an algorithm that assessed whether pre-therapy pathogens were eradicated or persisted as demonstrated by comparative characterization of recovered bacteria.
Time Frame
Day 4 - Test Of Cure (TOC) compared to Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ocular inflammation associated with blepharaconjunctivitis
Exclusion Criteria:
ocular allergy
ocular disorders that would preclude safe administration of test article
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Brubaker, BSN MPH
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
12. IPD Sharing Statement
Learn more about this trial
TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension
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