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

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00576251
First received: December 17, 2007
Last updated: February 23, 2010
Last verified: February 2010
History of Changes
  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
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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Judy Vittitoe, Alcon Research
ClinicalTrials.gov 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
blepharaconjunctivitis

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

ClinicalTrials.gov processed this record on May 19, 2013