Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle

The purpose of this study is to compare the new formulation of Tobradex to the current approved...

Date First Received: November 28, 2006

Last Updated: September 10, 2007

Verified by: Alcon Research, September 2007

Clinical Trial Phase: Phase 3 | Start Date: December 2006

Overall Status: Withdrawn

Estimated Enrollment: 700

Brief Summary

Official Title: “Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle”

Condition Keyword(s):

The purpose of this study is to compare the new formulation of Tobradex to the current approved formulation

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

  • Drug: Tobradex (Antibiotic steroid combination)

Outcome Measures for this Clinical Trial

Primary Measures

  • Anterior chamber inflammation

Secondary Measures

  • Aqueous cells and flare
  • ocular pain
  • physician's impression of infection
  • frequency of treatment failures

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Patients scheduled for cataract extraction

Exclusion Criteria:

  • Under 18 years

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 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

Terry Wiernas 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/NCT00404937

Study ID Number: C-05-60

ClinicalTrials.gov Identifier: NCT00404937

Health Authority: France: Institutional Ethical Committee

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