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...
Date First Received: May 10, 2007
Last Updated: July 28, 2008
Verified by: Alcon Research, July 2008
Clinical Trial Phase: Phase 3 | Start Date: November 2006
Overall Status: Completed
Estimated Enrollment: 900
Brief Summary
Official Title: “A Clinical Study of Tobradex AF”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Bio-equivalence Study
Study Primary Completion Date: February 2007
Intervention(s) in this Clinical Trial
- Drug: Tobradex AF
Outcome Measures for this Clinical Trial
Primary Measures
- Concentration of dexamethasone in aqueous humor following a single topical ocular administration
- Time Frame: Periodic
- Time Frame: Periodic
Secondary Measures
- Changes in external and internal ocular structures, intraocular pressure, vision and other side effects
- Time Frame: Periodic
- Time Frame: Periodic
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Adult patients requiring cataract surgery
Exclusion Criteria:
- Age related
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Alcon Research
Overall Clinical Trial Officials and Contacts
Robert Faulkner Study Director Alcon Research
Additional Information
Information obtained from ClinicalTrials.gov on August 28, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00473070
Study ID Number: C-06-37
ClinicalTrials.gov Identifier: NCT00473070
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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