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Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

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ClinicalTrials.gov Identifier: NCT00853970
Recruitment Status : Completed
First Posted : March 2, 2009
Results First Posted : January 26, 2011
Last Update Posted : January 25, 2013
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
Efficacy study of Bromfenac Ophthalmic Solution in cataract surgery

Condition or disease Intervention/treatment Phase
Pain Inflammation Drug: Bromfenac Ophthalmic Solution Drug: Placebo Comparator Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 299 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : February 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Summed Ocular Inflammation Score (SOIS) of Zero [ Time Frame: Day 15 (Primary Endpoint) ]
    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 :
  1. Pain Free [ Time Frame: Day 1 ]
    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.



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:

  • 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

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): NCT00853970


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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00853970     History of Changes
Other Study ID Numbers: CL-S&E-1205081-P
First Posted: March 2, 2009    Key Record Dates
Results First Posted: January 26, 2011
Last Update Posted: January 25, 2013
Last Verified: January 2013

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

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
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