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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00333918
Recruitment Status : Completed
First Posted : June 6, 2006
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Inflammation Drug: bromfenac ophthalmic solution Drug: placebo comparator Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 522 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : June 2006
Primary Completion Date : March 2007
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Eye Care
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1-bromfenac ophthalmic solution
sterile ophthalmic solution
Drug: bromfenac ophthalmic solution
Placebo Comparator: 2-placebo comparator
sterile ophthalmic solution
Drug: placebo comparator



Primary Outcome Measures :
  1. Reduction of ocular inflammation

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


Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333918


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

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00333918     History of Changes
Other Study ID Numbers: ISTA-BR-CS02
First Posted: June 6, 2006    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013

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

Additional relevant MeSH terms:
Inflammation
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Bromfenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents