Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery
January 11, 2013 updated by: Bausch & Lomb Incorporated
Efficacy study of Bromfenac Ophthalmic Solution in cataract surgery
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
299
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Irvine, California, United States, 92618
- ISTA Pharmaceuticals, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Bromfenac ophthalmic solution 0.09%
dosed 1 drop daily in study eye for 2 weeks
|
sterile ophthalmic solution
|
|
Placebo Comparator: Placebo
dosed 1 drop daily in study eye for 2 weeks
|
sterile ophthalmic solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Summed Ocular Inflammation Score (SOIS) of Zero
Time Frame: Day 15 (Primary Endpoint)
|
Participants with SOIS of 0. Measured on a scale of 0-4: 0=0 cells (complete absence); 0.5=1-5 cells ; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)
|
Day 15 (Primary Endpoint)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Free
Time Frame: Day 1
|
Participants that are pain free at day 1, taken from patient questionnaire with multiple possible responses measured on a scale of 0-3, where 0=none and 3=severe.
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
February 26, 2009
First Submitted That Met QC Criteria
February 27, 2009
First Posted (Estimate)
March 2, 2009
Study Record Updates
Last Update Posted (Estimate)
January 25, 2013
Last Update Submitted That Met QC Criteria
January 11, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CL-S&E-1205081-P
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.