A Clinical Study of Tobradex AF
This study has been completed.
Sponsor:
Alcon Research
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00473070
First received: May 10, 2007
Last updated: July 28, 2008
Last verified: July 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cataract |
Drug: Tobradex AF |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Clinical Study of Tobradex AF |
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Concentration of dexamethasone in aqueous humor following a single topical ocular administration [ Time Frame: Periodic ]
Secondary Outcome Measures:
- Changes in external and internal ocular structures, intraocular pressure, vision and other side effects [ Time Frame: Periodic ]
| Estimated Enrollment: | 900 |
| Study Start Date: | November 2006 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients requiring cataract surgery
Exclusion Criteria:
- Age related
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00473070
Please refer to this study by its ClinicalTrials.gov identifier: NCT00473070
Locations
| United States, Pennsylvania | |
| Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15122 | |
Sponsors and Collaborators
Alcon Research
Investigators
| Study Director: | Robert Faulkner | Alcon Research |
More Information
| ClinicalTrials.gov Identifier: | NCT00473070 History of Changes |
| Other Study ID Numbers: | C-06-37 |
| Study First Received: | May 10, 2007 |
| Last Updated: | July 28, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cataract Lens Diseases Eye Diseases |
ClinicalTrials.gov processed this record on September 29, 2016