TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension
Overview
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
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: February 2008
Interventions
- Drug: Tobramycin 0.3%/Dexamethasone 0.05%
- Tobramycin 0.3%/Dexamethasone 0.05% 1 drop in both eyes 4 times daily for at least 3 days
- Drug: TOBRADEX
- TOBRADEX 1 drop in both eyes 4 times daily for at least 3 days
Arms, Groups and Cohorts
- Experimental: Tobramycin 0.3%/Dexamethasone 0.05%
- Tobramycin 0.3%/Dexamethasone 0.05% 1 drop 4 times daily in both eyes
- Active Comparator: TOBRADEX
- TOBRADEX 1 drop 4 times daily in both eyes
Clinical Trial Outcome Measures
Primary Measures
- Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4)
- Time Frame: 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.
Participating in This Clinical Trial
Inclusion Criteria
- Ocular inflammation associated with blepharaconjunctivitis Exclusion Criteria:
- ocular allergy – ocular disorders that would preclude safe administration of test article
Gender Eligibility: All
Minimum Age: 2 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Alcon Research
- Provider of Information About this Clinical Study
- Judy Vittitoe, Alcon Research
- Overall Official(s)
- Michael Brubaker, BSN MPH, Study Director, Alcon Research
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