Efficacy of Ketorolac 0.4% in Prostaglandin Suppression

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: November 12, 2008
Last updated: September 21, 2011
Last verified: September 2011
A pilot study to evaluate the extent of PGE2 inhibition (mean aqueous values) by Ketorolac 0.04% following peripheral iridotomy

Condition Intervention Phase
Drug: Ketorolac 0.4%
Drug: Lubricating Eye Drop
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science

Resource links provided by NLM:

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Mean Prostaglandin E2 (PGE2) Aqueous Humor Levels [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    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).

Enrollment: 9
Study Start Date: November 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients scheduled to undergo phakic IOL implantation

Exclusion Criteria:

  • History of intraocular surgery in the operative eye
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00791323

United States, Texas
Houston, Texas, United States
Sponsors and Collaborators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00791323     History of Changes
Other Study ID Numbers: MA-ACU-08-001 
Study First Received: November 12, 2008
Results First Received: August 17, 2011
Last Updated: September 21, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pathologic Processes
Ketorolac Tromethamine
Lubricant Eye Drops
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Ophthalmic Solutions
Peripheral Nervous System Agents
Pharmaceutical Solutions
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on May 23, 2016