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
  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:


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
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, see Learn About Clinical Studies.

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
Pharmaceutical Solutions
Ophthalmic Solutions
Bromfenac
Therapeutic Uses
Pharmacologic Actions
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
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014