TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension
1 other identifier
interventional
221
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2007
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 17, 2007
CompletedFirst Posted
Study publicly available on registry
December 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedResults Posted
Study results publicly available
January 14, 2010
CompletedMarch 2, 2010
February 1, 2010
4 months
December 17, 2007
September 25, 2009
February 23, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4)
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.
Day 4 - Test Of Cure (TOC) compared to Day 0
Study Arms (2)
Tobramycin 0.3%/Dexamethasone 0.05%
EXPERIMENTALTobramycin 0.3%/Dexamethasone 0.05% 1 drop 4 times daily in both eyes
TOBRADEX
ACTIVE COMPARATORTOBRADEX 1 drop 4 times daily in both eyes
Interventions
Tobramycin 0.3%/Dexamethasone 0.05% 1 drop in both eyes 4 times daily for at least 3 days
Eligibility Criteria
You may qualify if:
- Ocular inflammation associated with blepharaconjunctivitis
You may not qualify if:
- ocular allergy
- ocular disorders that would preclude safe administration of test article
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Houston
Houston, Texas, 77090, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alcon Clinical
- Organization
- Alcon Research, Ltd
Study Officials
- STUDY DIRECTOR
Michael Brubaker, BSN MPH
Alcon Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 17, 2007
First Posted
December 19, 2007
Study Start
October 1, 2007
Primary Completion
February 1, 2008
Study Completion
March 1, 2008
Last Updated
March 2, 2010
Results First Posted
January 14, 2010
Record last verified: 2010-02