Back to resultsA Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery
Primary Purpose
Cataract Extraction
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ketorolac eye drops
Sponsored by
About this trial
This is an interventional treatment trial for Cataract Extraction
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing cataract surgery
Exclusion Criteria:
- Uncontrolled ocular disease in cataract surgery eye
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Ocular Pain
Measured on a scale of 0-4 (0 = none, 4 = intolerable)
Mean Pupil Area
Pupil area post-irrigation and aspiration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00521456
Brief Title
A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Extraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
263 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ketorolac eye drops
Intervention Description
1 drop twice daily day preop and Days 1-14, and 6 doses on surgery day
Placebo
Primary Outcome Measure Information:
Title
Resolution of Post Operative Inflammation
Description
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)
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
Ocular Pain
Description
Measured on a scale of 0-4 (0 = none, 4 = intolerable)
Time Frame
Day 1
Title
Mean Pupil Area
Description
Pupil area post-irrigation and aspiration
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing cataract surgery
Exclusion Criteria:
Uncontrolled ocular disease in cataract surgery eye
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
San Diego
State/Province
California
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21145532
Citation
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.
Results Reference
derived
Links:
URL
http://www.allerganclinicaltrials.com/inquiries/trialsubject.aspx
Description
Related Info
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A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery
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