Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00404937
First received: November 28, 2006
Last updated: March 3, 2012
Last verified: September 2007
  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

Resource links provided by NLM:


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
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
No Contacts or Locations Provided
  More Information

No publications provided

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
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on April 15, 2014