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Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

This study has been completed.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated Identifier:
First received: February 26, 2009
Last updated: January 11, 2013
Last verified: January 2013
Efficacy study of Bromfenac Ophthalmic Solution in cataract surgery

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 (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Summed Ocular Inflammation Score (SOIS) of Zero [ Time Frame: Day 15 (Primary Endpoint) ] [ Designated as safety issue: No ]
    Participants with SOIS of 0. Measured on a scale of 0-4: 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:
  • Pain Free [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Participants that are pain free at day 1, taken from patient questionnaire with multiple possible responses measured on a scale of 0-3, where 0=none and 3=severe.

Enrollment: 299
Study Start Date: February 2009
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bromfenac ophthalmic solution 0.09%
dosed 1 drop daily in study eye for 2 weeks
Drug: Bromfenac Ophthalmic Solution
sterile ophthalmic solution
Placebo Comparator: Placebo
dosed 1 drop daily in study eye for 2 weeks
Drug: Placebo Comparator
sterile ophthalmic solution


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

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
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: NCT00853970

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bausch & Lomb Incorporated Identifier: NCT00853970     History of Changes
Other Study ID Numbers: CL-S&E-1205081-P 
Study First Received: February 26, 2009
Results First Received: November 15, 2010
Last Updated: January 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bausch & Lomb Incorporated:
Pain and Inflammation as a function of cataract surgery

Additional relevant MeSH terms:
Pathologic Processes
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 October 28, 2016