Efficacy of Ketorolac 0.4% in Prostaglandin Supression

This study is currently recruiting participants.

Verified by Allergan, May 2009

First Received: November 12, 2008 Last Updated: May 13, 2009 History of Changes

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00791323

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 IV

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study

Resource links provided by NLM:

Drug Information available for: Ketorolac Ketorolac tromethamine

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Mean PGE2 aqueous levels [ Time Frame: Day 3 ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	November 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Ketorolac 0.4%	Drug: Ketorolac 0.4% One drop 4 times a day in the pre-operative eye beginning day 0 for 4 days
2: Placebo Comparator Mineral Oil 1%	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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients scheduled to undergo phakic IOL implantation

Exclusion Criteria:

History of intraocular surgery in the operative eye

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791323

Contacts

Contact: Allergan Inc

clinicaltrials@allergan.com

Locations

United States, Texas
	Recruiting
Houston, Texas, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	MA-ACU-08-001
Study First Received:	November 12, 2008
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00791323 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Anti-Inflammatory Agents
Analgesics, Non-Narcotic
Cyclooxygenase Inhibitors
Ketorolac
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents

Analgesics
Tetrahydrozoline
Antirheumatic Agents
Ketorolac Tromethamine
Inflammation

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Ketorolac
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Inflammation
Pathologic Processes

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009