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A Clinical Study of Tobradex AF

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00473070
First Posted: May 14, 2007
Last Update Posted: July 29, 2008
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 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 Intervention Phase
Cataract Drug: Tobradex AF Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Clinical Study of Tobradex AF

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Concentration of dexamethasone in aqueous humor following a single topical ocular administration [ Time Frame: Periodic ]

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

Estimated Enrollment: 900
Study Start Date: November 2006
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Adult patients requiring cataract surgery

Exclusion Criteria:

  • Age related
  Contacts and Locations
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
United States, Pennsylvania
Pittsburgh
Pittsburgh, Pennsylvania, United States, 15122
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Robert Faulkner Alcon Research
  More Information

ClinicalTrials.gov Identifier: NCT00473070     History of Changes
Other Study ID Numbers: C-06-37
First Submitted: May 10, 2007
First Posted: May 14, 2007
Last Update Posted: July 29, 2008
Last Verified: July 2008

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases