Back to resultsEfficacy of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery
Primary Purpose
Pain, Inflammation, Cataract
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bromfenac Ophthalmic Solution
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring cataract surgery
Eligibility Criteria
Inclusion Criteria:
- Male or female at least 18 years of age who are scheduled for unilateral cataract surgery
Exclusion Criteria:
- Have known hypersensitivity to bromfenac or to any component of the investigational product
Sites / Locations
- ISTA Pharmaceuticals, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bromfenac Ophthalmic Solution
Placebo
Arm Description
Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.
One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.
Outcomes
Primary Outcome Measures
Ocular Inflammation
The proportion of subjects who had cleared ocular inflammation summed ocular inflammation score (SOIS) of grade 0 by Day 15.
Secondary Outcome Measures
Ocular Pain
The proportion of subjects who were free of ocular pain at Day 1. Pain Free defined as a score of "None" on the pain scale of the Ocular Comfort Grading Assessment in the subject diary.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01367249
Brief Title
Efficacy of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery
Official Title
Efficacy and Safety of Bromfenac Ophthalmic Solution vs. Placebo for the Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
December 2011 (Actual)
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 an efficacy study of Bromfenac Ophthalmic Solution in cataract surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Inflammation, Cataract
Keywords
cataract surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
440 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bromfenac Ophthalmic Solution
Arm Type
Experimental
Arm Description
Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.
Intervention Type
Drug
Intervention Name(s)
Bromfenac Ophthalmic Solution
Intervention Description
Sterile ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sterile ophthalmic solution
Primary Outcome Measure Information:
Title
Ocular Inflammation
Description
The proportion of subjects who had cleared ocular inflammation summed ocular inflammation score (SOIS) of grade 0 by Day 15.
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Ocular Pain
Description
The proportion of subjects who were free of ocular pain at Day 1. Pain Free defined as a score of "None" on the pain scale of the Ocular Comfort Grading Assessment in the subject diary.
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female at least 18 years of age who are scheduled for unilateral cataract surgery
Exclusion Criteria:
Have known hypersensitivity to bromfenac or to any component of the investigational product
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 of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery
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