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Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

This study has been completed.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated Identifier:
First received: June 20, 2008
Last updated: January 11, 2013
Last verified: January 2013
Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Condition Intervention Phase
Drug: Bromfenac
Drug: Placebo
Phase 3

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

Resource links provided by NLM:

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero [ Time Frame: Day 15 ]
    Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)

Secondary Outcome Measures:
  • Number of Participants That Are Pain Free [ Time Frame: Day 1 ]
    Participant description of being pain free (Score of none)taken from patient questionnaire, Ocular Comfort Grading Assessment with multiple possible responses

Enrollment: 156
Study Start Date: June 2008
Study Completion Date: December 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bromfenac
Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
Drug: Bromfenac
sterile ophthalmic solution
Placebo Comparator: Placebo
Placebo, dosed 1 drop daily
Drug: Placebo
sterile ophthalmic solution


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

Inclusion Criteria:

  • Scheduled for cataract surgery

Exclusion Criteria:

  • Known hypersensitivity to bromfenac and salicylates
  Contacts and Locations
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Please refer to this study by its identifier: NCT00704418

United States, California
ISTA Pharmaceuticals, Inc.
Irvine, California, United States, 92618
Sponsors and Collaborators
Bausch & Lomb Incorporated
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bausch & Lomb Incorporated Identifier: NCT00704418     History of Changes
Other Study ID Numbers: CL-S&E-0415081-P-WR
Study First Received: June 20, 2008
Results First Received: November 15, 2010
Last Updated: January 11, 2013

Keywords provided by Bausch & Lomb Incorporated:
Cataract extraction
intraocular lens implantation

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on April 28, 2017