Efficacy and Safety of Bromfenac Ophthalmic Solution

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00585975
First received: December 21, 2007
Last updated: February 13, 2013
Last verified: February 2013
  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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00585975     History of Changes
Other Study ID Numbers: CL-S&E-0802071-P
Study First Received: December 21, 2007
Results First Received: November 7, 2011
Last Updated: February 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
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 July 22, 2014