TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension
Phase 3
Completed
- Conditions
- Ocular Inflammation Associated With Blepharaconjunctivitis
- Interventions
- Registration Number
- NCT00576251
- Lead Sponsor
- Alcon Research
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 221
Inclusion Criteria
- Ocular inflammation associated with blepharaconjunctivitis
Exclusion Criteria
- ocular allergy
- ocular disorders that would preclude safe administration of test article
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tobramycin 0.3%/Dexamethasone 0.05% Tobramycin 0.3%/Dexamethasone 0.05% Tobramycin 0.3%/Dexamethasone 0.05% 1 drop 4 times daily in both eyes TOBRADEX TOBRADEX TOBRADEX 1 drop 4 times daily in both eyes
- Primary Outcome Measures
Name Time Method Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4) Day 4 - Test Of Cure (TOC) compared to Day 0 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
Name Time Method
Trial Locations
- Locations (1)
Houston
🇺🇸Houston, Texas, United States