Back to resultsA Clinical Study of Tobradex AF
Primary Purpose
Cataract
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tobradex AF
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
Inclusion Criteria:
- Adult patients requiring cataract surgery
Exclusion Criteria:
- Age related
Sites / Locations
- Pittsburgh
Outcomes
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, intraocular pressure, vision and other side effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00473070
Brief Title
A Clinical Study of Tobradex AF
Official Title
A Clinical Study of Tobradex AF
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Alcon Research
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
900 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tobradex AF
Primary Outcome Measure Information:
Title
Concentration of dexamethasone in aqueous humor following a single topical ocular administration
Time Frame
Periodic
Secondary Outcome Measure Information:
Title
Changes in external and internal ocular structures, intraocular pressure, vision and other side effects
Time Frame
Periodic
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients requiring cataract surgery
Exclusion Criteria:
Age related
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Faulkner
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15122
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study of Tobradex AF
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