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Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00703781
Recruitment Status : Completed
First Posted : June 24, 2008
Results First Posted : December 9, 2011
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Condition or disease Intervention/treatment Phase
Cataract Drug: bromfenac ophthalmic solution Drug: placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : June 2008
Primary Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Eye Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)


Secondary Outcome Measures :
  1. Number of Participants That Are Pain Free [ Time Frame: Day 1 ]
    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


Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Scheduled for cataract surgery

Exclusion Criteria:

  • Known hypersensitivity to bromfenac and salicylates
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00703781


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

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00703781     History of Changes
Other Study ID Numbers: CL-S&E-0415081-P-ER
First Posted: June 24, 2008    Key Record Dates
Results First Posted: December 9, 2011
Last Update Posted: March 24, 2015
Last Verified: March 2015

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

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Bromfenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents