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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
History of Changes
  Purpose

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
Pain
Inflammation
 Drug: bromfenac ophthalmic solution
Drug: placebo comparator
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Reduction of ocular inflammation [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary efficacy outcome for ocular pain will be the proportion of treated subjects that are pain free [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00333918     History of Changes
Other Study ID Numbers: ISTA-BR-CS02
Study First Received: June 4, 2006
Last Updated: February 13, 2013
Health Authority: United States: Food and Drug Administration

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
Bromfenac
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Therapeutic Uses
 Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013