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Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00853970
First received: February 26, 2009
Last updated: January 11, 2013
Last verified: January 2013
History of Changes
  Purpose

Efficacy study of Bromfenac Ophthalmic Solution in cataract surgery


Condition Intervention Phase
Pain
Inflammation
 Drug: Bromfenac Ophthalmic Solution
Drug: Placebo Comparator
 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:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Summed Ocular Inflammation Score (SOIS) of Zero [ Time Frame: Day 15 (Primary Endpoint) ] [ Designated as safety issue: No ]
    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:
  • Pain Free [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.


Enrollment: 299
Study Start Date: February 2009
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided by Bausch & Lomb Incorporated

Additional 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
Study First Received: February 26, 2009
Results First Received: November 15, 2010
Last Updated: January 11, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Bromfenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013