Safety/Efficacy of Bromfenac Ophthalmic Solution for Ocular Inflammation and Pain Associated With Cataract Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00333918
First received: June 4, 2006
Last updated: February 13, 2013
Last verified: February 2013

June 4, 2006
February 13, 2013
June 2006
March 2007   (final data collection date for primary outcome measure)
Reduction of ocular inflammation [ Designated as safety issue: No ]
Reduction of ocular inflammation.
Complete list of historical versions of study NCT00333918 on ClinicalTrials.gov Archive Site
Secondary efficacy outcome for ocular pain will be the proportion of treated subjects that are pain free [ Designated as safety issue: No ]
Secondary efficacy outcome for ocular pain will be the proportion of treated subjects that are pain free.
Not Provided
Not Provided
 
Safety/Efficacy of Bromfenac Ophthalmic Solution for Ocular Inflammation and Pain Associated With Cataract Surgery
Efficacy and Safety Study of Topical Bromfenac Ophthalmic Solution vs. Placebo for Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery

The primary objective of this study is to investigate the efficacy and safety of bromfenac ophthalmic solution for treatment of ocular inflammation and pain in subjects who undergo cataract extraction and intraocular lens implantation.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Pain
  • Inflammation
  • Drug: bromfenac ophthalmic solution
  • Drug: placebo comparator
  • Experimental: 1-bromfenac ophthalmic solution
    sterile ophthalmic solution
    Intervention: Drug: bromfenac ophthalmic solution
  • Placebo Comparator: 2-placebo comparator
    sterile ophthalmic solution
    Intervention: Drug: placebo comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
522
March 2007
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Scheduled for unilateral cataract surgery with no other ophthalmic surgical procedures planned during cataract surgery
  • Agree to return for all required visits
  • Agree to avoid disallowed medications

Exclusion Criteria:

  • Known hypersensitivity to bromfenac and salicylates
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00333918
ISTA-BR-CS02
Not Provided
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Ralph Bianca, PhD ISTA Pharmaceuticals, Inc.
Bausch & Lomb Incorporated
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP