Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle
This study has been withdrawn prior to recruitment.
Sponsored by: Alcon Research
Information provided by: Alcon Research
ClinicalTrials.gov Identifier: NCT00404937
  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 III

Drug Information available for: Tobramycin Tobramycin sulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Estimated Enrollment: 700
Study Start Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for cataract extraction

Exclusion Criteria:

  • Under 18 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00404937

Locations
France
Bordeaux
Bordeaux, France, 33000
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Terry Wiernas Alcon Research
  More Information

Study ID Numbers: C-05-60
Study First Received: November 28, 2006
Last Updated: September 10, 2007
ClinicalTrials.gov Identifier: NCT00404937  
Health Authority: France: Institutional Ethical Committee

Study placed in the following topic categories:
Tobramycin
Inflammation

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009