This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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% 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
TOBRADEX 1 drop in both eyes 4 times daily for at least 3 days


Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Alcon Research:
Ocular inflammation

Additional relevant MeSH terms:
Pathologic Processes
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
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 processed this record on September 21, 2017