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Efficacy and Safety of Bromfenac Ophthalmic Solution

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00585975
First Posted: January 4, 2008
Last Update Posted: February 15, 2013
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.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
  Purpose
This is a safety and efficacy study of bromfenac ophthalmic solution

Condition Intervention Phase
Cataract Surgery Drug: bromfenac ophthalmic solution Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 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:
  • 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


Enrollment: 568
Study Start Date: October 2007
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bromfenac Ophthalmic Solution 0.18% Drug: bromfenac ophthalmic solution
sterile opthalmic solution
Experimental: Xibrom 0.09% Drug: bromfenac ophthalmic solution
sterile opthalmic solution

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 Submitted: December 21, 2007
First Posted: January 4, 2008
Results First Submitted: November 7, 2011
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