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A Clinical Study of Tobradex AF

This study has been completed.
Information provided by:
Alcon Research Identifier:
First received: May 10, 2007
Last updated: July 28, 2008
Last verified: July 2008
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
Drug: Tobradex AF
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

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

Inclusion Criteria:

  • Adult patients requiring cataract surgery

Exclusion Criteria:

  • Age related
  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.

Please refer to this study by its identifier: NCT00473070

United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15122
Sponsors and Collaborators
Alcon Research
Study Director: Robert Faulkner Alcon Research
  More Information Identifier: NCT00473070     History of Changes
Other Study ID Numbers: C-06-37 
Study First Received: May 10, 2007
Last Updated: July 28, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases processed this record on December 06, 2016