TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension

This study has been completed.
Information provided by:
Alcon Research Identifier:
First received: December 17, 2007
Last updated: February 23, 2010
Last verified: February 2010
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

Condition Intervention Phase
Ocular Inflammation Associated With Blepharaconjunctivitis
Drug: Tobramycin 0.3%/Dexamethasone 0.05%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Alcon Research:

Primary Outcome 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 ] [ Designated as safety issue: No ]
    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.

Enrollment: 221
Study Start Date: October 2007
Estimated Study Completion Date: March 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tobramycin 0.3%/Dexamethasone 0.05%
Tobramycin 0.3%/Dexamethasone 0.05% 1 drop 4 times daily in both eyes
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
Active Comparator: TOBRADEX
TOBRADEX 1 drop 4 times daily in both eyes
TOBRADEX 1 drop in both eyes 4 times daily for at least 3 days


Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ocular inflammation associated with blepharaconjunctivitis

Exclusion Criteria:

  • ocular allergy
  • ocular disorders that would preclude safe administration of test article
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Please refer to this study by its identifier: NCT00576251

United States, Texas
Houston, Texas, United States, 77090
Sponsors and Collaborators
Alcon Research
Study Director: Michael Brubaker, BSN MPH Alcon Research
  More Information

Responsible Party: Judy Vittitoe, Alcon Research Identifier: NCT00576251     History of Changes
Other Study ID Numbers: C-07-19 
Study First Received: December 17, 2007
Results First Received: September 25, 2009
Last Updated: February 23, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Ocular inflammation

Additional relevant MeSH terms:
Pathologic Processes
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses processed this record on May 02, 2016