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Efficacy of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01367249
First received: June 1, 2011
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

This is an efficacy study of Bromfenac Ophthalmic Solution in cataract surgery.


Condition Intervention Phase
Pain
Inflammation
Cataract
 Drug: Bromfenac Ophthalmic Solution
Drug: Placebo Comparator
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

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:
  • Level of post surgical inflammation [ Time Frame: Day 15 ] [ Designated as safety issue: No ]

Enrollment: 440
Study Start Date: May 2011
Study Completion Date: December 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bromfenac Ophthalmic Solution
Sterile ophthalmic solution
 Drug: Bromfenac Ophthalmic Solution
Sterile ophthalmic solution
Placebo Comparator: Placebo Comparator
Sterile ophthalmic solution
 Drug: Placebo Comparator
Sterile ophthalmic solution

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female at least 18 years of age who are scheduled for unilateral cataract surgery

Exclusion Criteria:

  • Have known hypersensitivity to bromfenac or to any component of the investigational product
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367249

Locations
United States, California
ISTA Pharmaceuticals, Inc.
Irvine, California, United States, 92618
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Tim McNamara, PharmD ISTA Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01367249     History of Changes
Other Study ID Numbers: S00124
Study First Received: June 1, 2011
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bausch & Lomb Incorporated:
cataract surgery

Additional relevant MeSH terms:
Inflammation
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases
Bromfenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013