Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle
This study has been withdrawn prior to enrollment.
Sponsor:
Alcon Research
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00404937
First received: November 28, 2006
Last updated: March 3, 2012
Last verified: September 2007
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Purpose
The purpose of this study is to compare the new formulation of Tobradex to the current approved formulation
| Condition | Intervention | Phase |
|---|---|---|
|
Post-surgical Inflammation |
Drug: Tobradex (Antibiotic steroid combination) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle |
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Anterior chamber inflammation
Secondary Outcome Measures:
- Aqueous cells and flare
- ocular pain
- physician's impression of infection
- frequency of treatment failures
| Enrollment: | 0 |
| Study Start Date: | December 2006 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | December 2006 (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:
- Patients scheduled for cataract extraction
Exclusion Criteria:
- Under 18 years
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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No Contacts or Locations Provided
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More Information
| ClinicalTrials.gov Identifier: | NCT00404937 History of Changes |
| Other Study ID Numbers: | C-05-60 |
| Study First Received: | November 28, 2006 |
| Last Updated: | March 3, 2012 |
| Health Authority: | France: Institutional Ethical Committee |
Additional relevant MeSH terms:
|
Inflammation Pathologic Processes Anti-Bacterial Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on September 30, 2016