Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00703781
First received: June 20, 2008
Last updated: January 11, 2013
Last verified: January 2013
  Purpose

Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery


Condition Intervention Phase
Cataract
Drug: bromfenac ophthalmic solution
Drug: placebo
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:
  • Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    Participants with SOIS of 0. 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 (None, Mild, Moderate, Severe) within one hour of instilling eye drop


Enrollment: 126
Study Start Date: June 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bromfenac
Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
Drug: bromfenac ophthalmic solution
sterile ophthalmic solution
Placebo Comparator: Placebo
Placebo, Dosed 1 Drop Daily
Drug: placebo
sterile ophthalmic solution

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled for cataract surgery

Exclusion Criteria:

  • Known hypersensitivity to bromfenac and salicylates
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703781

Locations
United States, California
ISTA Pharmaceuticals, Inc.
Irvine, California, United States, 92618
Sponsors and Collaborators
Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00703781     History of Changes
Other Study ID Numbers: CL-S&E-0415081-P-ER
Study First Received: June 20, 2008
Results First Received: November 7, 2011
Last Updated: January 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bausch & Lomb Incorporated:
Cataract extraction with intraocular lens implantation

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 April 16, 2014