Efficacy of Ketorolac 0.4% in Prostaglandin Suppression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00791323
First received: November 12, 2008
Last updated: September 21, 2011
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Inflammation
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00791323

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

No publications provided

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:
Inflammation
Pathologic Processes
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014