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Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle

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.
 
ClinicalTrials.gov Identifier: NCT00404937
Recruitment Status : Withdrawn
First Posted : November 29, 2006
Last Update Posted : March 6, 2012
Sponsor:
Information provided by:
Alcon Research

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle
Study Start Date : December 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006



Primary Outcome Measures :
  1. Anterior chamber inflammation

Secondary Outcome Measures :
  1. Aqueous cells and flare
  2. ocular pain
  3. physician's impression of infection
  4. frequency of treatment failures


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients scheduled for cataract extraction

Exclusion Criteria:

  • Under 18 years
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ClinicalTrials.gov Identifier: NCT00404937    
Other Study ID Numbers: C-05-60
First Posted: November 29, 2006    Key Record Dates
Last Update Posted: March 6, 2012
Last Verified: September 2007
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Anti-Bacterial Agents
Tobramycin, Dexamethasone Drug Combination
Anti-Infective Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Ophthalmic Solutions
Pharmaceutical Solutions