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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