Back to resultsEfficacy and Safety of Bromfenac Ophthalmic Solution
Primary Purpose
Cataract Surgery
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bromfenac ophthalmic solution
Sponsored by
About this trial
This is an interventional treatment trial for Cataract Surgery
Eligibility 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
Sites / Locations
- ISTA Pharmaceuticals, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Bromfenac Ophthalmic Solution 0.18%
Xibrom 0.09%
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero
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
Participant description of being pain free taken from patient questionnaire with multiple possible responses
Full Information
NCT ID
NCT00585975
First Posted
December 21, 2007
Last Updated
February 13, 2013
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00585975
Brief Title
Efficacy and Safety of Bromfenac Ophthalmic Solution
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a safety and efficacy study of bromfenac ophthalmic solution
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
568 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bromfenac Ophthalmic Solution 0.18%
Arm Type
Experimental
Arm Title
Xibrom 0.09%
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
bromfenac ophthalmic solution
Intervention Description
sterile opthalmic solution
Primary Outcome Measure Information:
Title
Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero
Description
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)
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Number of Participants That Are Pain Free
Description
Participant description of being pain free taken from patient questionnaire with multiple possible responses
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim McNamara, PharmD
Organizational Affiliation
ISTA Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
ISTA Pharmaceuticals, Inc.
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Bromfenac Ophthalmic Solution
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