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Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle

This study has been withdrawn prior to enrollment.
Information provided by:
Alcon Research Identifier:
First received: November 28, 2006
Last updated: March 3, 2012
Last verified: September 2007
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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)

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

Inclusion Criteria:

  • Patients scheduled for cataract extraction

Exclusion Criteria:

  • Under 18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information Identifier: NCT00404937     History of Changes
Other Study ID Numbers: C-05-60 
Study First Received: November 28, 2006
Last Updated: March 3, 2012
Health Authority: France: Institutional Ethical Committee

Additional relevant MeSH terms:
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents processed this record on January 18, 2017