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Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00404937
First Posted: November 29, 2006
Last Update Posted: March 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Alcon Research
  Purpose
The purpose of this study is to compare the new formulation of Tobradex to the current approved formulation

Condition Intervention Phase
Post-surgical Inflammation Drug: Tobradex (Antibiotic steroid combination) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Anterior chamber inflammation

Secondary Outcome Measures:
  • Aqueous cells and flare
  • ocular pain
  • physician's impression of infection
  • frequency of treatment failures
Enrollment: 0
Study Start Date: December 2006
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for cataract extraction

Exclusion Criteria:

  • Under 18 years
  Contacts and Locations
No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT00404937     History of Changes
Other Study ID Numbers: C-05-60
First Submitted: November 28, 2006
First Posted: November 29, 2006
Last Update Posted: March 6, 2012
Last Verified: September 2007

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents