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

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

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

Secondary Measures

  • Microbiological
    • Time Frame: Week 5
      Safety Issue?: Yes

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

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