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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
History of Changes
  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:

MedlinePlus related topics: Cataract
U.S. FDA Resources

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
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 May 19, 2013