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Efficacy of Ketorolac 0.4% in Prostaglandin Suppression

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ClinicalTrials.gov Identifier: NCT00791323
Recruitment Status : Completed
First Posted : November 14, 2008
Results First Posted : September 23, 2011
Last Update Posted : September 23, 2011
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
A pilot study to evaluate the extent of PGE2 inhibition (mean aqueous values) by Ketorolac 0.04% following peripheral iridotomy

Condition or disease Intervention/treatment Phase
Inflammation Drug: Ketorolac 0.4% Drug: Lubricating Eye Drop Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Study Start Date : November 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Ketorolac

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Ketorolac 0.4%
 Drug: Ketorolac 0.4%
One drop 4 times a day in the pre-operative eye beginning day 0 for 4 days
Other Name: Acular LS™
Active Comparator: 2
Mineral Oil Emollient
 Drug: Lubricating Eye Drop
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
Other Name: Soothe® XP


Outcome Measures
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Primary Outcome Measures :
  1. Mean Prostaglandin E2 (PGE2) Aqueous Humor Levels [ Time Frame: Day 3 ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled to undergo phakic IOL implantation

Exclusion Criteria:

  • History of intraocular surgery in the operative eye
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791323


Locations
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United States, Texas
Houston, Texas, United States
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00791323    
Other Study ID Numbers: MA-ACU-08-001
First Posted: November 14, 2008    Key Record Dates
Results First Posted: September 23, 2011
Last Update Posted: September 23, 2011
Last Verified: September 2011
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Ketorolac
Ophthalmic Solutions
Lubricant Eye Drops
Pharmaceutical Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action