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A Clinical Study of Tobradex AF

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: NCT00473070
Recruitment Status : Completed
First Posted : May 14, 2007
Last Update Posted : July 29, 2008
Sponsor:
Information provided by:
Alcon Research

Study Description
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Brief Summary:
The purpose of this study is to determine the amount of study medication that moves from the front of the eye into the fluid at the front of the inside of the eye.

Condition or disease Intervention/treatment Phase
Cataract Drug: Tobradex AF Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Clinical Study of Tobradex AF
Study Start Date : November 2006
Actual Primary Completion Date : February 2007
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Concentration of dexamethasone in aqueous humor following a single topical ocular administration [ Time Frame: Periodic ]

Secondary Outcome Measures :
  1. Changes in external and internal ocular structures, intraocular pressure, vision and other side effects [ Time Frame: Periodic ]

Eligibility Criteria
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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:

  • Adult patients requiring cataract surgery

Exclusion Criteria:

  • Age related
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00473070


Locations
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United States, Pennsylvania
Pittsburgh
Pittsburgh, Pennsylvania, United States, 15122
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Robert Faulkner Alcon Research
More Information
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ClinicalTrials.gov Identifier: NCT00473070    
Other Study ID Numbers: C-06-37
First Posted: May 14, 2007    Key Record Dates
Last Update Posted: July 29, 2008
Last Verified: July 2008
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Tobramycin, Dexamethasone Drug Combination
Anti-Inflammatory Agents
Anti-Bacterial Agents
Anti-Infective Agents
 Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Ophthalmic Solutions
Pharmaceutical Solutions