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Efficacy and Safety of Bromfenac Ophthalmic Solution

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: NCT00585975
Recruitment Status : Completed
First Posted : January 4, 2008
Results First Posted : December 9, 2011
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a safety and efficacy study of bromfenac ophthalmic solution

Condition or disease Intervention/treatment Phase
Cataract Surgery Drug: bromfenac ophthalmic solution Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 568 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2007
Primary Completion Date : July 2008

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: Bromfenac Ophthalmic Solution 0.18% Drug: bromfenac ophthalmic solution
sterile opthalmic solution
Experimental: Xibrom 0.09% Drug: bromfenac ophthalmic solution
sterile opthalmic 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 1. 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


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:   Yes
Criteria

Inclusion Criteria:

  • Male or female greater than or equal to 18 years of age, and scheduled for cataract surgery

Exclusion Criteria:

  • Active corneal pathology in either eye
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): NCT00585975


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

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00585975     History of Changes
Other Study ID Numbers: CL-S&E-0802071-P
First Posted: January 4, 2008    Key Record Dates
Results First Posted: December 9, 2011
Last Update Posted: February 15, 2013
Last Verified: February 2013

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