Ocular Inflammation Associated With Blepharaconjunctivitis Clinical Trial
| Verified date | February 2010 |
| Source | Alcon Research |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 221 |
| Est. completion date | March 2008 |
| Est. primary completion date | February 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 2 Years and older |
| Eligibility |
Inclusion Criteria: - Ocular inflammation associated with blepharaconjunctivitis Exclusion Criteria: - ocular allergy - ocular disorders that would preclude safe administration of test article |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Houston | Houston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Alcon Research |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Day 4 - Test Of Cure (TOC) compared to Day 0 | No |