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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

December 17, 2007
February 23, 2010
October 2007
February 2008   (final data collection date for primary outcome measure)
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.
Ocular inflammation at Visits 2-5 [ Time Frame: 2 -5 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00576251 on ClinicalTrials.gov Archive Site
Not Provided
Microbiologiocal [ Time Frame: Week 5 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension
Not Provided

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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ocular Inflammation Associated With Blepharaconjunctivitis
  • 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
  • Experimental: Tobramycin 0.3%/Dexamethasone 0.05%
    Tobramycin 0.3%/Dexamethasone 0.05% 1 drop 4 times daily in both eyes
    Intervention: Drug: Tobramycin 0.3%/Dexamethasone 0.05%
  • Active Comparator: TOBRADEX
    TOBRADEX 1 drop 4 times daily in both eyes
    Intervention: Drug: TOBRADEX
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
221
March 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ocular inflammation associated with blepharaconjunctivitis

Exclusion Criteria:

  • ocular allergy
  • ocular disorders that would preclude safe administration of test article
Both
2 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00576251
C-07-19
No
Judy Vittitoe, Alcon Research
Alcon Research
Not Provided
Study Director: Michael Brubaker, BSN MPH Alcon Research
Alcon Research
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP