- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00703781
Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery
March 4, 2015 updated by: Bausch & Lomb Incorporated
Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
126
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:
- Scheduled for cataract surgery
Exclusion Criteria:
- Known hypersensitivity to bromfenac and salicylates
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
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Bromfenac
Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
|
sterile ophthalmic solution
|
PLACEBO_COMPARATOR: Placebo
Placebo, Dosed 1 Drop Daily
|
sterile ophthalmic solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Day 15
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
June 1, 2008
Primary Completion (ACTUAL)
November 1, 2008
Study Registration Dates
First Submitted
June 20, 2008
First Submitted That Met QC Criteria
June 23, 2008
First Posted (ESTIMATE)
June 24, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
March 24, 2015
Last Update Submitted That Met QC Criteria
March 4, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CL-S&E-0415081-P-ER
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.
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