Working… Menu

Efficacy of Ketorolac 0.4% in Prostaglandin Suppression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00791323
Recruitment Status : Completed
First Posted : November 14, 2008
Results First Posted : September 23, 2011
Last Update Posted : September 23, 2011
Information provided by (Responsible Party):

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

Layout table for study information
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

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

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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients scheduled to undergo phakic IOL implantation

Exclusion Criteria:

  • History of intraocular surgery in the operative eye

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 identifier (NCT number): NCT00791323

Layout table for location information
United States, Texas
Houston, Texas, United States
Sponsors and Collaborators
Layout table for investigator information
Study Director: Medical Director Allergan
Layout table for additonal information
Responsible Party: Allergan 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:
Layout table for MeSH terms
Pathologic Processes
Ophthalmic Solutions
Lubricant Eye Drops
Pharmaceutical Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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