Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery
1 other identifier
interventional
299
1 country
1
Brief Summary
Efficacy study of Bromfenac Ophthalmic Solution in cataract surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 pain
Started Feb 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 26, 2009
CompletedFirst Posted
Study publicly available on registry
March 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
January 26, 2011
CompletedJanuary 25, 2013
January 1, 2013
7 months
February 26, 2009
November 15, 2010
January 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Summed Ocular Inflammation Score (SOIS) of Zero
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 Outcomes (1)
Pain Free
Day 1
Study Arms (2)
Bromfenac ophthalmic solution 0.09%
EXPERIMENTALdosed 1 drop daily in study eye for 2 weeks
Placebo
PLACEBO COMPARATORdosed 1 drop daily in study eye for 2 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Male or female at least 18 years of age who are scheduled for unilateral cataract surgery
You may not qualify if:
- Have known hypersensitivity to bromfenac or to any component of the investigational product
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ISTA Pharmaceuticals, Inc.
Irvine, California, 92618, United States
Related Publications (1)
Silverstein SM, Cable MG, Sadri E, Peace JH, Fong R, Chandler SP, Gow JA, Klier SM, McNamara TR; Bromfenac Ophthalmic Solution Once Daily (Bromday) Study Group. Once daily dosing of bromfenac ophthalmic solution 0.09% for postoperative ocular inflammation and pain. Curr Med Res Opin. 2011 Sep;27(9):1693-703. doi: 10.1185/03007995.2011.597663. Epub 2011 Jul 14.
PMID: 21751945DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tim McNamara, Vice President, Clinical Research & Medical Affairs
- Organization
- ISTA Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Tim McNamara, PharmD
ISTA Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2009
First Posted
March 2, 2009
Study Start
February 1, 2009
Primary Completion
September 1, 2009
Study Completion
December 1, 2009
Last Updated
January 25, 2013
Results First Posted
January 26, 2011
Record last verified: 2013-01