Efficacy of Ketorolac 0.4% in Prostaglandin Suppression
1 other identifier
interventional
9
1 country
1
Brief Summary
A pilot study to evaluate the extent of PGE2 inhibition (mean aqueous values) by Ketorolac 0.04% following peripheral iridotomy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2008
Shorter than P25 for phase_4
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
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 12, 2008
CompletedFirst Posted
Study publicly available on registry
November 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
September 23, 2011
CompletedSeptember 23, 2011
September 1, 2011
9 months
November 12, 2008
August 17, 2011
September 21, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Day 3
Study Arms (2)
1
ACTIVE COMPARATORKetorolac 0.4%
2
ACTIVE COMPARATORMineral Oil Emollient
Interventions
One drop 4 times a day in the pre-operative eye beginning day 0 for 4 days
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
Eligibility Criteria
You may qualify if:
- Patients scheduled to undergo phakic IOL implantation
You may not qualify if:
- History of intraocular surgery in the operative eye
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
Houston, Texas, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President Medical Affairs
- 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 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2008
First Posted
November 14, 2008
Study Start
November 1, 2008
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
September 23, 2011
Results First Posted
September 23, 2011
Record last verified: 2011-09