A Bioequivalence Study of Tobradex AF

This study has been completed.

First Received: August 9, 2006 Last Updated: May 10, 2007 History of Changes

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00362895

Purpose

The purpose of the 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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Bio-equivalence Study
Official Title:	A Double-Masked, Parallel-Group, Randomized, Single-Dose Bioequivalence Study of Tobradex AF Suspension and TOBRADEX Ophthalmic Suspension

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

Secondary Outcome Measures:

changes in external and internal ocular structures, IOP, vision and other side effects

Estimated Enrollment:	1000
Study Start Date:	April 2006

Eligibility

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

Criteria

Inclusion Criteria:

Adult patients only

Exclusion Criteria:

children

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362895

Locations

United States, Texas
Houston
Houston, Texas, United States, 77027

Sponsors and Collaborators

Alcon Research

Investigators

Study Director:

Robert Faulkner

817-551-4887

More Information

No publications provided

Study ID Numbers:	C-05-23
Study First Received:	August 9, 2006
Last Updated:	May 10, 2007
ClinicalTrials.gov Identifier:	NCT00362895 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Eye Diseases
Cataract
Lens Diseases

Additional relevant MeSH terms:

Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on September 02, 2009