Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle

Post-surgical Inflammation Clinical Trial

Official title:

Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00404937
• Other study ID #: C-05-60
• Status: Withdrawn
• Phase: Phase 3
• First received: November 28, 2006
• Last updated: March 3, 2012
• Start date: December 2006
• Est. completion date: December 2006

Study information

• Verified date: September 2007
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the new formulation of Tobradex to the current approved formulation

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled for cataract extraction

Exclusion Criteria:

• Under 18 years

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Post-surgical Inflammation

Intervention

Drug:
• Tobradex (Antibiotic steroid combination)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anterior chamber inflammation
Secondary	Aqueous cells and flare
Secondary	ocular pain
Secondary	physician's impression of infection
Secondary	frequency of treatment failures