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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00576251
First Posted: December 19, 2007
Last Update Posted: March 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Alcon Research
  Purpose
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% Drug: TOBRADEX Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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
Drug: TOBRADEX
TOBRADEX 1 drop in both eyes 4 times daily for at least 3 days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ocular inflammation associated with blepharaconjunctivitis

Exclusion Criteria:

  • ocular allergy
  • ocular disorders that would preclude safe administration of test article
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576251


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

Responsible Party: Judy Vittitoe, Alcon Research
ClinicalTrials.gov Identifier: NCT00576251     History of Changes
Other Study ID Numbers: C-07-19
First Submitted: December 17, 2007
First Posted: December 19, 2007
Results First Submitted: September 25, 2009
Results First Posted: January 14, 2010
Last Update Posted: March 2, 2010
Last Verified: February 2010

Keywords provided by Alcon Research:
Ocular inflammation
blepharaconjunctivitis

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Dexamethasone acetate
Dexamethasone
BB 1101
Tobramycin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents