Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

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

Condition Intervention Phase
Drug: bromfenac ophthalmic solution
Drug: placebo comparator
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of Topical Bromfenac Ophthalmic Solution vs. Placebo for Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery

Resource links provided by NLM:

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Reduction of ocular inflammation

Secondary Outcome Measures:
  • Secondary efficacy outcome for ocular pain will be the proportion of treated subjects that are pain free

Enrollment: 522
Study Start Date: June 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1-bromfenac ophthalmic solution
sterile ophthalmic solution
Drug: bromfenac ophthalmic solution
Placebo Comparator: 2-placebo comparator
sterile ophthalmic solution
Drug: placebo comparator


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  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 identifier: NCT00333918

United States, California
Irvine, California, United States, 92618
Sponsors and Collaborators
Bausch & Lomb Incorporated
Study Director: Ralph Bianca, PhD ISTA Pharmaceuticals, Inc.
  More Information

Responsible Party: Bausch & Lomb Incorporated Identifier: NCT00333918     History of Changes
Other Study ID Numbers: ISTA-BR-CS02
Study First Received: June 4, 2006
Last Updated: February 13, 2013

Keywords provided by Bausch & Lomb Incorporated:
Cataract Extraction
Anti-Inflammatory Agents, Non-Steroidal

Additional relevant MeSH terms:
Pathologic Processes
Lens Diseases
Eye Diseases
Pharmaceutical Solutions
Anti-Inflammatory Agents, Non-Steroidal
Ophthalmic Solutions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on May 24, 2017