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...
Date First Received: August 9, 2006
Last Updated: May 10, 2007
Verified by: Alcon Research, May 2007
Clinical Trial Phase: Phase 3 | Start Date: April 2006
Overall Status: Completed
Estimated Enrollment: 1000
Brief Summary
Official Title: “A Double-Masked, Parallel-Group, Randomized, Single-Dose Bioequivalence Study of Tobradex AF Suspension and TOBRADEX Ophthalmic Suspension”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Bio-equivalence Study
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
Secondary Measures
- changes in external and internal ocular structures, IOP, vision and other side effects
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Adult patients only
Exclusion Criteria:
- children
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 817-551-4887
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00362895
Study ID Number: C-05-23
ClinicalTrials.gov Identifier: NCT00362895
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
