A Clinical Study of Tobradex AF

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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...

Brief Summary

Official Title: “A Clinical Study of Tobradex AF”

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: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
  • 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

Secondary Measures

  • Changes in external and internal ocular structures, intraocular pressure, vision and other side effects
    • 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 Investigator Information

Lead Investigator: Alcon Research Industry

Overall Clinical Trial Officials and Contacts

Robert Faulkner Study Director Alcon Research  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00473070