Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 ophthalmic solution
Drug: placebo
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:
  • Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 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 ] [ Designated as safety issue: No ]
    Participant description of being pain free taken from patient questionnaire with multiple possible responses (None, Mild, Moderate, Severe) within one hour of instilling eye drop

Enrollment: 126
Study Start Date: June 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bromfenac
Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
Drug: bromfenac ophthalmic solution
sterile ophthalmic solution
Placebo Comparator: Placebo
Placebo, Dosed 1 Drop Daily
Drug: placebo
sterile ophthalmic solution


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

Inclusion Criteria:

  • Scheduled for cataract surgery

Exclusion Criteria:

  • Known hypersensitivity to bromfenac and salicylates
  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: NCT00703781

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

No publications provided

Responsible Party: Bausch & Lomb Incorporated Identifier: NCT00703781     History of Changes
Other Study ID Numbers: CL-S&E-0415081-P-ER
Study First Received: June 20, 2008
Results First Received: November 7, 2011
Last Updated: January 11, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Ophthalmic Solutions
Pharmaceutical Solutions
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on March 03, 2015