A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery
1 other identifier
interventional
248
1 country
1
Brief Summary
This is a 16-day study to evaluate the safety and efficacy of ketorolac eye drops for the treatment of inflammation and pain associated with 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
Started Oct 2007
Shorter than P25 for phase_3
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
First Submitted
Initial submission to the registry
August 30, 2007
CompletedFirst Posted
Study publicly available on registry
September 3, 2007
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
October 1, 2009
CompletedOctober 1, 2009
August 1, 2009
6 months
August 30, 2007
August 19, 2009
September 29, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Resolution of Post Operative Inflammation
Anterior chamber inflammation is the sum of biomicroscopic cell and flare; each measured on a scale of 0-4 (Flare: 0 = no flare, 4 = intense flare / Cell: 0 = no cells, 4 = \>50 cells)
Day 14
Secondary Outcomes (2)
Ocular Pain
Day 1
Mean Pupil Area
Day 0
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Patients undergoing cataract surgery
You may not qualify if:
- Uncontrolled ocular disease in cataract surgery eye
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
Artesia, California, United States
Related Publications (1)
Donnenfeld ED, Nichamin LD, Hardten DR, Raizman MB, Trattler W, Rajpal RK, Alpern LM, Felix C, Bradford RR, Villanueva L, Hollander DA, Schiffman RM. Twice-daily, preservative-free ketorolac 0.45% for treatment of inflammation and pain after cataract surgery. Am J Ophthalmol. 2011 Mar;151(3):420-6.e1. doi: 10.1016/j.ajo.2010.09.003. Epub 2010 Dec 9.
PMID: 21145532DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
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
Study Record Dates
First Submitted
August 30, 2007
First Posted
September 3, 2007
Study Start
October 1, 2007
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
October 1, 2009
Results First Posted
October 1, 2009
Record last verified: 2009-08