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

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

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 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

ClinicalTrials.gov processed this record on February 27, 2015

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