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...
Date First Received: December 17, 2007
Last Updated: March 24, 2008
Verified by: Alcon Research, March 2008
Clinical Trial Phase: Phase 3 | Start Date: October 2007
Overall Status: Completed
Estimated Enrollment: 200
Brief Summary
Condition Keyword(s):
Intervention(s):
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
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: TOBRADEX
- Drug as needed
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- TOBRADEX and Tobramycin 0.3%/Dexamethasone 0.05%
Outcome Measures for this Clinical Trial
Primary Measures
- Ocular inflammation at Visits 2-5
- Time Frame: 2 -5 weeks
Safety Issue?: Yes
- Time Frame: 2 -5 weeks
Secondary Measures
- Microbiological
- Time Frame: Week 5
Safety Issue?: Yes
- Time Frame: Week 5
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Ocular inflammation associated with blepharaconjunctivitis
Exclusion Criteria:
- Age
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 2 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Alcon Research
Overall Clinical Trial Officials and Contacts
Michael Brubaker, BSN MPH Study Director Alcon Research
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00576251
Study ID Number: C-07-19
ClinicalTrials.gov Identifier: NCT00576251
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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