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A Clinical Study of Tobradex AF

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00473070
First received: May 10, 2007
Last updated: July 28, 2008
Last verified: July 2008
History of Changes
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Clinical Study of Tobradex AF

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients requiring cataract surgery

Exclusion Criteria:

  • Age related
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013