Back to resultsEfficacy of Ketorolac 0.4% in Prostaglandin Suppression
Primary Purpose
Inflammation
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketorolac 0.4%
Lubricating Eye Drop
Sponsored by
About this trial
This is an interventional basic science trial for Inflammation
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled to undergo phakic IOL implantation
Exclusion Criteria:
- History of intraocular surgery in the operative eye
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Ketorolac 0.4%
Mineral Oil Emollient
Outcomes
Primary Outcome Measures
Mean Prostaglandin E2 (PGE2) Aqueous Humor Levels
The mean level of PGE2 (a naturally occurring prostaglandin E2 in the eye that can cause inflammation and other complications) in the aqueous humor (the thin, watery fluid in the eye) 2 days following peripheral iridotomy (ocular surgery).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00791323
Brief Title
Efficacy of Ketorolac 0.4% in Prostaglandin Suppression
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A pilot study to evaluate the extent of PGE2 inhibition (mean aqueous values) by Ketorolac 0.04% following peripheral iridotomy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Ketorolac 0.4%
Arm Title
2
Arm Type
Active Comparator
Arm Description
Mineral Oil Emollient
Intervention Type
Drug
Intervention Name(s)
Ketorolac 0.4%
Other Intervention Name(s)
Acular LS™
Intervention Description
One drop 4 times a day in the pre-operative eye beginning day 0 for 4 days
Intervention Type
Drug
Intervention Name(s)
Lubricating Eye Drop
Other Intervention Name(s)
Soothe® XP
Intervention Description
One drop 4 times a day in the operative eye beginning one day prior to the peripheral iridotomy and continuing until the day of IOL implantation
Primary Outcome Measure Information:
Title
Mean Prostaglandin E2 (PGE2) Aqueous Humor Levels
Description
The mean level of PGE2 (a naturally occurring prostaglandin E2 in the eye that can cause inflammation and other complications) in the aqueous humor (the thin, watery fluid in the eye) 2 days following peripheral iridotomy (ocular surgery).
Time Frame
Day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled to undergo phakic IOL implantation
Exclusion Criteria:
History of intraocular surgery in the operative eye
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Houston
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Ketorolac 0.4% in Prostaglandin Suppression
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