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Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00703781
First Posted: June 24, 2008
Last Update Posted: March 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
  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 (Participant, 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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled for cataract surgery

Exclusion Criteria:

  • Known hypersensitivity to bromfenac and salicylates
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00703781


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

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00703781     History of Changes
Other Study ID Numbers: CL-S&E-0415081-P-ER
First Submitted: June 20, 2008
First Posted: June 24, 2008
Results First Submitted: November 7, 2011
Results First Posted: December 9, 2011
Last Update Posted: March 24, 2015
Last Verified: March 2015

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

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Bromfenac
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