Efficacy of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery
Efficacy and Safety of Bromfenac Ophthalmic Solution vs. Placebo for the Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery.
1 other identifier
interventional
440
1 country
1
Brief Summary
This is an 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 P75+ for phase_3 pain
Started May 2011
Shorter than P25 for phase_3 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 1, 2011
CompletedFirst Posted
Study publicly available on registry
June 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
May 6, 2014
CompletedMay 6, 2014
April 1, 2014
2 months
June 1, 2011
April 4, 2014
April 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ocular Inflammation
The proportion of subjects who had cleared ocular inflammation summed ocular inflammation score (SOIS) of grade 0 by Day 15.
Day 15
Secondary Outcomes (1)
Ocular Pain
Day 1
Study Arms (2)
Bromfenac Ophthalmic Solution
EXPERIMENTALBromfenac 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.
Placebo
PLACEBO COMPARATOROne 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.
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- James Gow
- Organization
- Bausch & Lomb Incorporated
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
June 1, 2011
First Posted
June 7, 2011
Study Start
May 1, 2011
Primary Completion
July 1, 2011
Study Completion
December 1, 2011
Last Updated
May 6, 2014
Results First Posted
May 6, 2014
Record last verified: 2014-04